Who is sponsoring NCT01687413?

NCT01687413 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT01687413?

Interventions in NCT01687413: Intensity-modulated radiation therapy (IMRT), Cisplatin.

What condition does NCT01687413 study?

NCT01687413 studies Oropharyngeal Neoplasms.

Is NCT01687413 still recruiting?

NCT01687413 is currently terminated. Last updated 25 November 2020.

Are results published for NCT01687413?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-25 · How we verify

NCT01687413: ADEPT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer

Terminated Phase 3 Results posted Last updated 25 November 2020

What this trial tests

Phase 3 trial testing Intensity-modulated radiation therapy (IMRT) in Oropharyngeal Neoplasms in 42 participants. Terminated before completion.

Timeline

10 January 2013

Primary endpoint
18 October 2019

18 October 2019

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	10 January 2013
Primary completion	18 October 2019
Estimated completion	18 October 2019
Sites	2 locations across United States

Drugs / interventions tested

Intensity-modulated radiation therapy (IMRT)
Cisplatin (cisplatin) — full drug profile →

Conditions studied

Oropharyngeal Neoplasms — all drugs for Oropharyngeal Neoplasms →

Sponsor

Washington University School of Medicine

Who can join

21 and older, any sex, with Oropharyngeal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Disease-free Survival (DFS) Primary · 1 year

Group	Value	95% CI
Radiotherapy	24
Radiotherapy, Cisplatin	10

Locoregional Control Primary · Up to 2 years

Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.

Group	Value	95% CI
Radiotherapy	26
Radiotherapy, Cisplatin	9

Rate of Distant Metastasis Secondary · Up to 2 years

Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.

Group	Value	95% CI
Radiotherapy	2
Radiotherapy, Cisplatin	0

Disease Specific Survival Secondary · 1 year

Group	Value	95% CI
Radiotherapy	24
Radiotherapy, Cisplatin	10

Number of Complications/Acute Toxicity by Organ Class Secondary · Approximately 18 weeks

-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Blood and lymphatic system disorders

Group	Value	95% CI
Radiotherapy	5
Radiotherapy, Cisplatin	12

Cardiac disorders

Group	Value	95% CI
Radiotherapy	0
Radiotherapy, Cisplatin	1

Ear and labyrinth disorders

Group	Value	95% CI
Radiotherapy	11
Radiotherapy, Cisplatin	4

Eye disorders

Group	Value	95% CI
Radiotherapy	2
Radiotherapy, Cisplatin	0

Gastrointestinal disorders

Group	Value	95% CI
Radiotherapy	104
Radiotherapy, Cisplatin	61

General disorders

Group	Value	95% CI
Radiotherapy	38
Radiotherapy, Cisplatin	17

Immune system disorders

Group	Value	95% CI
Radiotherapy	1
Radiotherapy, Cisplatin	0

Infections and infestations

Group	Value	95% CI
Radiotherapy	7
Radiotherapy, Cisplatin	2

Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory Secondary · Baseline, 1 month, 6 months, 12 months, and 24 months

* Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5 * The lower the score the lower the quality of life

My swallowing ability limits my day to day activities.

Group	Value	95% CI
Baseline - Radiotherapy	3.2608696	± 1.3888318
Baseline - Radiotherapy + Cisplatin	4.0000000	± 1.0954451
1 Month - Radiotherapy	4.1818182	± 1.2203186
1 Month - Radiotherapy + Cisplatin	4.1818182	± 1.1677484
6 Months - Radiotherapy	4.3076923	± 0.9473309
6 Months - Radiotherapy + Cisplatin	3.5714286	± 1.5118579
12 Months - Radiotherapy	4.5000000	± 0.6504436
12 Months - Radiotherapy + Cisplatin	3.2857143	± 1.6035675
24 Months - Radiotherapy	3.9375000	± 1.3889444
24 Months - Radiotherapy + Cisplatin	4.6250000	± 0.5175492

I am embarrassed by my eating habits.

Group	Value	95% CI
Baseline - Radiotherapy	3.5454545	± 1.2993505
Baseline - Radiotherapy + Cisplatin	4.4545455	± 0.8201995
1 Month - Radiotherapy	4.1818182	± 1.2587357
1 Month - Radiotherapy + Cisplatin	4.4545455	± 0.5222330
6 Months - Radiotherapy	4.3846154	± 1.1208971
6 Months - Radiotherapy + Cisplatin	3.8571429	± 0.6900656
12 Months - Radiotherapy	4.4285714	± 0.7559289
12 Months - Radiotherapy + Cisplatin	3.1428571	± 1.2149858
24 Months - Radiotherapy	4.1250000	± 1.2041595
24 Months - Radiotherapy + Cisplatin	4.1250000	± 0.6408699

Swallowing is more difficult at the end of the day.

Group	Value	95% CI
Baseline - Radiotherapy	3.3636364	± 1.4974726
Baseline - Radiotherapy + Cisplatin	4.5454545	± 0.6875517
1 Month - Radiotherapy	3.8095238	± 1.3273676
1 Month - Radiotherapy + Cisplatin	4.0909091	± 0.9438798
6 Months - Radiotherapy	4.6153846	± 0.8697185
6 Months - Radiotherapy + Cisplatin	3.8571429	± 1.0690450
12 Months - Radiotherapy	4.2857143	± 1.1387288
12 Months - Radiotherapy + Cisplatin	4.1428571	± 1.0690450
24 Months - Radiotherapy	4.4000000	± 0.9102590
24 Months - Radiotherapy + Cisplatin	4.7500000	± 0.4629100

I do not feel self-conscious when I eat.

Group	Value	95% CI
Baseline - Radiotherapy	3.3913043	± 1.3395769
Baseline - Radiotherapy + Cisplatin	4.0909091	± 1.2210279
1 Month - Radiotherapy	3.9090909	± 1.1087999
1 Month - Radiotherapy + Cisplatin	4.1818182	± 0.9816498
6 Months - Radiotherapy	4.3846154	± 0.9607689
6 Months - Radiotherapy + Cisplatin	3.7142857	± 1.1126973
12 Months - Radiotherapy	4.0769231	± 1.3204506
12 Months - Radiotherapy + Cisplatin	3.7142857	± 1.2535663
24 Months - Radiotherapy	3.6875000	± 1.3022417
24 Months - Radiotherapy + Cisplatin	4.5000000	± 0.7559289

I am upset by my swallowing problem.

Group	Value	95% CI
Baseline - Radiotherapy	3.2272727	± 1.6599431
Baseline - Radiotherapy + Cisplatin	2.0909091	± 1.5135749
1 Month - Radiotherapy	2.8636364	± 1.6123173
1 Month - Radiotherapy + Cisplatin	2.6363636	± 1.3618170
6 Months - Radiotherapy	3.1538462	± 1.6756170
6 Months - Radiotherapy + Cisplatin	2.2857143	± 1.2535663
12 Months - Radiotherapy	2.7857143	± 1.6723347
12 Months - Radiotherapy + Cisplatin	3.1428571	± 1.3451854
24 Months - Radiotherapy	3.0625000	± 1.7308476
24 Months - Radiotherapy + Cisplatin	3.2500000	± 1.4880476

People have difficulty cooking for me.

Group	Value	95% CI
Baseline - Radiotherapy	3.2173913	± 1.5062452
Baseline - Radiotherapy + Cisplatin	3.9090909	± 1.2210279
1 Month - Radiotherapy	3.7727273	± 1.3777766
1 Month - Radiotherapy + Cisplatin	4.2727273	± 1.0090500
6 Months - Radiotherapy	3.7692308	± 1.4806444
6 Months - Radiotherapy + Cisplatin	3.1428571	± 1.2149858
12 Months - Radiotherapy	4.2142857	± 1.1883131
12 Months - Radiotherapy + Cisplatin	3.7142857	± 1.3801311
24 Months - Radiotherapy	3.9375000	± 1.3400871
24 Months - Radiotherapy + Cisplatin	4.1250000	± 0.6408699

Swallowing takes great effort.

Group	Value	95% CI
Baseline - Radiotherapy	3.0869565	± 1.5049326
Baseline - Radiotherapy + Cisplatin	3.4545455	± 1.2135598
1 Month - Radiotherapy	3.9545455	± 1.0455016
1 Month - Radiotherapy + Cisplatin	3.9090909	± 1.2210279
6 Months - Radiotherapy	3.6923077	± 1.3155870
6 Months - Radiotherapy + Cisplatin	3.0000000	± 1.1547005
12 Months - Radiotherapy	3.9285714	± 1.3847680
12 Months - Radiotherapy + Cisplatin	3.1428571	± 1.5735916
24 Months - Radiotherapy	3.5625000	± 1.2632630
24 Months - Radiotherapy + Cisplatin	3.3750000	± 1.4078860

I do not go out because of my swallowing problem.

Group	Value	95% CI
Baseline - Radiotherapy	3.9130435	± 0.9960396
Baseline - Radiotherapy + Cisplatin	4.6363636	± 0.5045250
1 Month - Radiotherapy	4.3181818	± 0.9454837
1 Month - Radiotherapy + Cisplatin	4.1818182	± 0.9816498
6 Months - Radiotherapy	4.5384615	± 0.8770580
6 Months - Radiotherapy + Cisplatin	3.8571429	± 1.0690450
12 Months - Radiotherapy	4.6428571	± 0.6333237
12 Months - Radiotherapy + Cisplatin	4.1428571	± 1.0690450
24 Months - Radiotherapy	4.1875000	± 1.0468206
24 Months - Radiotherapy + Cisplatin	4.2500000	± 0.8864053

Change in Cognitive Function as Measured by Cognitive Failures Questionnaire Secondary · Baseline, 1 month, 12 months, and 24 months

* 25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering * Answers range from 0 = never to 4 = very often * The higher the score the worse the cognitive failures the participant has experienced

Do you read something and find you haven't been thinking about it and must read it again?

Group	Value	95% CI
Baseline - Radiotherapy	1.4166667	± 0.9743076
Baseline - Radiotherapy + Cisplatin	1.3636364	± 1.2060454
1 Month - Radiotherapy	1.5454545	± 1.0107646
1 Month - Radiotherapy + Cisplatin	1.2727273	± 0.7862454
12 Months - Radiotherapy	1.4666667	± 0.9154754
12 Months - Radiotherapy + Cisplatin	2.1666667	± 1.1690452
24 Months - Radiotherapy	1.5625000	± 0.7274384
24 Months - Radiotherapy + Cisplatin	1.5714286	± 1.1338934

Do you find you forget why you went from one part of the house to the other?

Group	Value	95% CI
Baseline - Radiotherapy	1.2083333	± 0.9770927
Baseline - Radiotherapy + Cisplatin	1.0909091	± 0.9438798
1 Month - Radiotherapy	1.2727273	± 1.1621744
1 Month - Radiotherapy + Cisplatin	1.0000000	± 1.0000000
12 Months - Radiotherapy	1.333333	± 1.3451854
12 Months - Radiotherapy + Cisplatin	1.5000000	± 0.8366600
24 Months - Radiotherapy	1.4375000	± 0.8920949
24 Months - Radiotherapy + Cisplatin	1.4285714	± 1.2724180

Do you fail to notice signposts on the road?

Group	Value	95% CI
Baseline - Radiotherapy	0.6666667	± 0.9168313
Baseline - Radiotherapy + Cisplatin	0.3636364	± 0.6741999
1 Month - Radiotherapy	0.7272727	± 0.9847319
1 Month - Radiotherapy + Cisplatin	0.5454545	± 0.6875517
12 Months - Radiotherapy	0.6666667	± 0.6172134
12 Months - Radiotherapy + Cisplatin	0.8333333	± 0.7527727
24 Months - Radiotherapy	0.6250000	± 0.6191392
24 Months - Radiotherapy + Cisplatin	0.8571429	± 1.0690450

Do you find you confuse right and left when giving directions?

Group	Value	95% CI
Baseline - Radiotherapy	0.3333333	± 0.8681147
Baseline - Radiotherapy + Cisplatin	0.2727273	± 0.4670994
1 Month - Radiotherapy	0.4545455	± 0.9116846
1 Month - Radiotherapy + Cisplatin	0.2727273	± 0.6466698
12 Months - Radiotherapy	0.2666667	± 0.5936168
12 Months - Radiotherapy + Cisplatin	0.3333333	± 0.5163978
24 Months - Radiotherapy	0.3750000	± 0.6191392
24 Months - Radiotherapy + Cisplatin	0.5714286	± 0.7867958

Do you bump into people?

Group	Value	95% CI
Baseline - Radiotherapy	0.2500000	± 0.5316095
Baseline - Radiotherapy + Cisplatin	0.1818182	± 0.4045199
1 Month - Radiotherapy	0.3636364	± 0.6579517
1 Month - Radiotherapy + Cisplatin	0.1818182	± 0.6030227
12 Months - Radiotherapy	0.4666667	± 0.7432234
12 Months - Radiotherapy + Cisplatin	0.8333333	± 1.3291601
24 Months - Radiotherapy	0.3125000	± 0.4787136
24 Months - Radiotherapy + Cisplatin	0.5714286	± 0.9759001

Do you find you forget whether you've turned off a light or a fire or locked the door?

Group	Value	95% CI
Baseline - Radiotherapy	0.9583333	± 0.9990938
Baseline - Radiotherapy + Cisplatin	0.6363636	± 0.6741999
1 Month - Radiotherapy	0.8636364	± 1.1252705
1 Month - Radiotherapy + Cisplatin	0.6363636	± 0.6741999
12 Months - Radiotherapy	1.1333333	± 1.0600988
12 Months - Radiotherapy + Cisplatin	1.3333333	± 0.5163978
24 Months - Radiotherapy	0.7333333	± 0.7037316
24 Months - Radiotherapy + Cisplatin	1.2857143	± 0.9511897

Do you fail to listen to people's names when you are meeting them?

Group	Value	95% CI
Baseline - Radiotherapy	1.7083333	± 1.3014763
Baseline - Radiotherapy + Cisplatin	1.0909091	± 1.3003496
1 Month - Radiotherapy	1.8181818	± 1.0970247
1 Month - Radiotherapy + Cisplatin	1.0909091	± 1.0444659
12 Months - Radiotherapy	2.0000000	± 1.1952286
12 Months - Radiotherapy + Cisplatin	1.3333333	± 1.0327959
24 Months - Radiotherapy	1.6250000	± 1.0246951
24 Months - Radiotherapy + Cisplatin	1.4285714	± 1.2724180

Do you say something and realize afterwards that it might be taken as insulting?

Group	Value	95% CI
Baseline - Radiotherapy	1.0000000	± 1.0632191
Baseline - Radiotherapy + Cisplatin	0.9090909	± 0.8312094
1 Month - Radiotherapy	1.0000000	± 1.1126973
1 Month - Radiotherapy + Cisplatin	0.8181818	± 0.6030227
12 Months - Radiotherapy	1.0666667	± 0.7988086
12 Months - Radiotherapy + Cisplatin	1.0000000	± 0.6324555
24 Months - Radiotherapy	1.2500000	± 1.0000000
24 Months - Radiotherapy + Cisplatin	0.8571429	± 1.4638501

Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) Secondary · Baseline, 12 months, and 24 months

-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from "not at all" to "a lot". The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).

Neck or shoulder pain or discomfort

Group	Value	95% CI
Baseline - Radiotherapy	1.6086957	± 1.1175920
Baseline - Radiotherapy + Cisplatin	2.0909091	± 1.2210279
12 Months - Radiotherapy	1.4666667	± 0.9904304
12 Months - Radiotherapy + Cisplatin	2.4285714	± 1.5118579
24 Months - Radiotherapy	1.3125000	± 0.8732125
24 Months - Radiotherapy + Cisplatin	1.7500000	± 1.2817399

Neck or shoulder stiffness

Group	Value	95% CI
Baseline - Radiotherapy	1.4545455	± 1.1433981
Baseline - Radiotherapy + Cisplatin	2.0000000	± 1.2649111
12 Months - Radiotherapy	1.0000000	± 0.8451543
12 Months - Radiotherapy + Cisplatin	2.4285714	± 1.5118579
24 Months - Radiotherapy	1.1875000	± 1.0468206
24 Months - Radiotherapy + Cisplatin	1.7500000	± 1.3887301

Difficulty with self-care activities because of neck or shoulder

Group	Value	95% CI
Baseline - Radiotherapy	0.8695652	± 0.9197009
Baseline - Radiotherapy + Cisplatin	1.2727273	± 1.1037127
12 Months - Radiotherapy	0.3333333	± 0.8164966
12 Months - Radiotherapy + Cisplatin	1.0000000	± 1.0000000
24 Months - Radiotherapy	0.2500000	± 0.5773503
24 Months - Radiotherapy + Cisplatin	0.5000000	± 1.4142136

Limited ability to life light objects because of your shoulder or neck

Group	Value	95% CI
Baseline - Radiotherapy	0.6521739	± 0.8846517
Baseline - Radiotherapy + Cisplatin	1.6363636	± 1.4333686
12 Months - Radiotherapy	0.4000000	± 0.7367884
12 Months - Radiotherapy + Cisplatin	0.8571429	± 1.0690450
24 Months - Radiotherapy	0.2500000	± 0.5773503
24 Months - Radiotherapy + Cisplatin	0.5000000	± 0.7559289

Limited ability to lift heavy objects because of your shoulder or neck

Group	Value	95% CI
Baseline - Radiotherapy	1.6086957	± 1.3395769
Baseline - Radiotherapy + Cisplatin	2.2727273	± 1.4206273
12 Months - Radiotherapy	0.5333333	± 0.9904304
12 Months - Radiotherapy + Cisplatin	1.5714286	± 1.7182494
24 Months - Radiotherapy	0.4666667	± 0.8338094
24 Months - Radiotherapy + Cisplatin	0.8750000	± 0.9910312

Limited ability to reach for objects because of your shoulder or neck

Group	Value	95% CI
Baseline - Radiotherapy	1.2173913	± 1.3802675
Baseline - Radiotherapy + Cisplatin	2.0909091	± 1.5135749
12 Months - Radiotherapy	0.5333333	± 0.8338094
12 Months - Radiotherapy + Cisplatin	1.7142857	± 1.6035675
24 Months - Radiotherapy	0.5625000	± 0.9639329
24 Months - Radiotherapy + Cisplatin	0.7500000	± 1.0350983

Overall activity level because of your shoulder or neck

Group	Value	95% CI
Baseline - Radiotherapy	1.0000000	± 1.2431631
Baseline - Radiotherapy + Cisplatin	1.9090909	± 1.5782614
12 Months - Radiotherapy	0.5333333	± 0.8338094
12 Months - Radiotherapy + Cisplatin	1.5714286	± 1.5118579
24 Months - Radiotherapy	0.3750000	± 0.6191392
24 Months - Radiotherapy + Cisplatin	0.6250000	± 0.7440238

Has the treatment of your neck affected your participation in social activities?

Group	Value	95% CI
Baseline - Radiotherapy	0.7391304	± 1.1368774
Baseline - Radiotherapy + Cisplatin	0.9090909	± 1.2210279
12 Months - Radiotherapy	0.0666667	± 0.2581989
12 Months - Radiotherapy + Cisplatin	0.8571429	± 0.8997354
24 Months - Radiotherapy	0.1875000	± 0.4031129
24 Months - Radiotherapy + Cisplatin	0.5000000	± 1.0690450

Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire Secondary · Baseline, 1 month, 6 months, 12 months, and 24 months

* It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness. * The higher the score the worse the participant's xerostomia

Rate your difficulty in talking due to dryness

Group	Value	95% CI
Baseline - Radiotherapy	2.3333333	± 2.4788964
Baseline - Radiotherapy + Cisplatin	1.3636364	± 2.2033033
1 Month - Radiotherapy	2.8095238	± 2.9089353
1 Month - Radiotherapy + Cisplatin	3.9090909	± 2.3855626
6 Months - Radiotherapy	3.0000000	± 2.9612887
6 Months - Radiotherapy + Cisplatin	4.8571429	± 3.2366944
12 Months - Radiotherapy	2.5625000	± 2.8276905
12 Months - Radiotherapy + Cisplatin	3.5714286	± 3.2071349
24 Months - Radiotherapy	3.6875000	± 2.9825884
24 Months - Radiotherapy + Cisplatin	3.1250000	± 2.7998724

Rate your difficulty chewing due to dryness

Group	Value	95% CI
Baseline - Radiotherapy	2.3913043	± 2.2711457
Baseline - Radiotherapy + Cisplatin	1.4545455	± 2.5831623
1 Month - Radiotherapy	3.5238095	± 2.6947922
1 Month - Radiotherapy + Cisplatin	3.1818182	± 2.8219916
6 Months - Radiotherapy	3.0714286	± 2.4326082
6 Months - Radiotherapy + Cisplatin	4.5714286	± 3.5523299
12 Months - Radiotherapy	2.6250000	± 2.2766935
12 Months - Radiotherapy + Cisplatin	3.7142857	± 3.8606686
24 Months - Radiotherapy	3.6250000	± 2.9183329
24 Months - Radiotherapy + Cisplatin	2.7500000	± 2.6592158

Rate your difficulty in swallowing solid food due to dryness

Group	Value	95% CI
Baseline - Radiotherapy	2.6956522	± 2.6532104
Baseline - Radiotherapy + Cisplatin	1.6363636	± 2.8380531
1 Month - Radiotherapy	3.4285714	± 2.5994505
1 Month - Radiotherapy + Cisplatin	3.9000000	± 2.9608557
6 Months - Radiotherapy	3.5000000	± 2.9807072
6 Months - Radiotherapy + Cisplatin	5.2857143	± 3.5456210
12 Months - Radiotherapy	3.3750000	± 3.0304015
12 Months - Radiotherapy + Cisplatin	4.1428571	± 3.5321651
24 Months - Radiotherapy	4.1250000	± 2.8722813
24 Months - Radiotherapy + Cisplatin	3.2500000	± 3.0118812

Rate the frequency of your sleeping problems due to dryness

Group	Value	95% CI
Baseline - Radiotherapy	1.7916667	± 1.8876985
Baseline - Radiotherapy + Cisplatin	1.5454545	± 2.8412545
1 Month - Radiotherapy	3.2857143	± 2.9179249
1 Month - Radiotherapy + Cisplatin	3.0000000	± 2.8982753
6 Months - Radiotherapy	1.7142857	± 2.0542104
6 Months - Radiotherapy + Cisplatin	4.4285714	± 2.8199966
12 Months - Radiotherapy	2.2500000	± 2.2656861
12 Months - Radiotherapy + Cisplatin	3.5714286	± 3.1014590
24 Months - Radiotherapy	2.6000000	± 2.8485585
24 Months - Radiotherapy + Cisplatin	2.7500000	± 2.4348658

Rate your mouth or throat dryness when eating food

Group	Value	95% CI
Baseline - Radiotherapy	2.2173913	± 2.1523037
Baseline - Radiotherapy + Cisplatin	1.8181818	± 3.0271499
1 Month - Radiotherapy	3.8571429	± 2.9203718
1 Month - Radiotherapy + Cisplatin	3.7272727	± 3.2277208
6 Months - Radiotherapy	3.5000000	± 2.8216198
6 Months - Radiotherapy + Cisplatin	5.7142857	± 3.0394235
12 Months - Radiotherapy	3.5000000	± 3.0767949
12 Months - Radiotherapy + Cisplatin	4.0000000	± 3.6968455
24 Months - Radiotherapy	3.8750000	± 3.0523215
24 Months - Radiotherapy + Cisplatin	3.3750000	± 3.0207615

Rate your mouth or throat dryness while not eating

Group	Value	95% CI
Baseline - Radiotherapy	2.1250000	± 2.1931217
Baseline - Radiotherapy + Cisplatin	1.5454545	± 2.3393861
1 Month - Radiotherapy	3.8571429	± 2.7979584
1 Month - Radiotherapy + Cisplatin	3.0909091	± 2.1191765
6 Months - Radiotherapy	2.6428571	± 2.8177226
6 Months - Radiotherapy + Cisplatin	4.7142857	± 2.4976179
12 Months - Radiotherapy	3.2500000	± 2.7446918
12 Months - Radiotherapy + Cisplatin	3.4285714	± 3.4572216
24 Months - Radiotherapy	3.7500000	± 3.1517191
24 Months - Radiotherapy + Cisplatin	2.6250000	± 2.7222627

Rate the frequency of sipping liquids to aid swallowing food

Group	Value	95% CI
Baseline - Radiotherapy	3.1739130	± 2.7741039
Baseline - Radiotherapy + Cisplatin	2.2727273	± 3.1013194
1 Month - Radiotherapy	5.1428571	± 3.2293299
1 Month - Radiotherapy + Cisplatin	4.0000000	± 3.4351128
6 Months - Radiotherapy	5.0000000	± 2.6602487
6 Months - Radiotherapy + Cisplatin	6.7142857	± 2.6903708
12 Months - Radiotherapy	5.0625000	± 3.5864328
12 Months - Radiotherapy + Cisplatin	5.0000000	± 3.6968455
24 Months - Radiotherapy	5.3125000	± 3.2397274
24 Months - Radiotherapy + Cisplatin	4.1250000	± 3.6815175

Rate the frequency of sipping liquids for oral comfort when not eating

Group	Value	95% CI
Baseline - Radiotherapy	2.9565217	± 2.7216015
Baseline - Radiotherapy + Cisplatin	2.0909091	± 2.8090762
1 Month - Radiotherapy	4.6190476	± 3.3388050
1 Month - Radiotherapy + Cisplatin	3.3636364	± 2.9076701
6 Months - Radiotherapy	3.4285714	± 3.1553199
6 Months - Radiotherapy + Cisplatin	5.2857143	± 2.7516229
12 Months - Radiotherapy	3.8750000	± 3.4229617
12 Months - Radiotherapy + Cisplatin	3.7142857	± 3.7733401
24 Months - Radiotherapy	4.0000000	± 3.4448028
24 Months - Radiotherapy + Cisplatin	2.7500000	± 3.3273756

Change in Hearing as Measured by Hearing Handicap Inventory - Adult Secondary · Baseline, 1 month, and 12 months

* 11 item questionnaire to identify issues with hearing * Answers are yes = 4, sometimes = 2, and no = 0 * The higher the score the more issues the participant has with hearing

Does a hearing problem cause you to feel embarrassed when you meet new people?

Group	Value	95% CI
Baseline - Radiotherapy	0.2500000	± 0.6079188
Baseline - Radiotherapy + Cisplatin	0.5454545	± 0.9341987
1 Month - Radiotherapy	0.2380952	± 0.6248809
1 Month - Radiotherapy + Cisplatin	0.1818182	± 0.6030227
12 Months - Radiotherapy	0.1333333	± 0.3518658
12 Months - Radiotherapy + Cisplatin	1.0000000	± 1.0000000

Does a hearing problem cause you to feel frustrated when talking to members of your family?

Group	Value	95% CI
Baseline - Radiotherapy	0.1250000	± 0.4484272
Baseline - Radiotherapy + Cisplatin	0.1818182	± 0.6030227
1 Month - Radiotherapy	0.5238095	± 0.8728716
1 Month - Radiotherapy + Cisplatin	0.3636364	± 0.8090398
12 Months - Radiotherapy	0.1333333	± 0.3518658
12 Months - Radiotherapy + Cisplatin	0.7142857	± 0.9511897

Do you have difficulty hearing or understanding co-workers or clients or customers?

Group	Value	95% CI
Baseline - Radiotherapy	0.5000000	± 0.8340577
Baseline - Radiotherapy + Cisplatin	1.0909091	± 1.0444659
1 Month - Radiotherapy	0.6666667	± 0.9128709
1 Month - Radiotherapy + Cisplatin	1.0909091	± 1.0444659
12 Months - Radiotherapy	0.1333333	± 0.3518658
12 Months - Radiotherapy + Cisplatin	1.7142857	± 0.4879500

Do you feel that any difficulty with your hearing limits or hampers your personal or social life?

Group	Value	95% CI
Baseline - Radiotherapy	0.1666667	± 0.4815434
Baseline - Radiotherapy + Cisplatin	0.6363636	± 0.9244163
1 Month - Radiotherapy	0.3809524	± 0.7400129
1 Month - Radiotherapy + Cisplatin	0.7272727	± 1.0090500
12 Months - Radiotherapy	0.2000000	± 0.5606119
12 Months - Radiotherapy + Cisplatin	0.7142857	± 0.9511897

Do you feel handicapped by a hearing problem?

Group	Value	95% CI
Baseline - Radiotherapy	0.1250000	± 0.4484272
Baseline - Radiotherapy + Cisplatin	0.5454545	± 0.9341987
1 Month - Radiotherapy	0.1428571	± 0.4780914
1 Month - Radiotherapy + Cisplatin	0.3636364	± 0.8090398
12 Months - Radiotherapy	0.0666667	± 0.2581989
12 Months - Radiotherapy + Cisplatin	0.7142857	± 0.9511897

Does a hearing problem cause you difficulty in the movies or in the theater?

Group	Value	95% CI
Baseline - Radiotherapy	0.1666667	± 0.4815434
Baseline - Radiotherapy + Cisplatin	0.4545455	± 0.8201995
1 Month - Radiotherapy	0.5238095	± 0.8728716
1 Month - Radiotherapy + Cisplatin	0.2727273	± 0.6466698
12 Months - Radiotherapy	0.1333333	± 0.5163978
12 Months - Radiotherapy + Cisplatin	0.4285714	± 0.7867958

Does a hearing problem cause you difficulty when in a restaurant with relatives or friends?

Group	Value	95% CI
Baseline - Radiotherapy	0.2173913	± 0.5997364
Baseline - Radiotherapy + Cisplatin	0.7272727	± 0.9045340
1 Month - Radiotherapy	0.6190476	± 0.8646497
1 Month - Radiotherapy + Cisplatin	0.8181818	± 0.9816498
12 Months - Radiotherapy	0.2666667	± 0.5936168
12 Months - Radiotherapy + Cisplatin	1.5714286	± 0.7867958

Does a hearing problem cause you to attend religious services less often than you would like?

Group	Value	95% CI
Baseline - Radiotherapy	0.0416667	± 0.2041241
Baseline - Radiotherapy + Cisplatin	0.1818182	± 0.6030227
1 Month - Radiotherapy	0.0000000	± 0.0000000
1 Month - Radiotherapy + Cisplatin	0.0000000	± 0.0000000
12 Months - Radiotherapy	0.0000000	± 0.0000000
12 Months - Radiotherapy + Cisplatin	0.0000000	± 0.0000000

Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity Secondary · Baseline, 1 month, 6 months, and 12 months

* 1 question that asks about taste acuity * Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity * The higher the score the worse the participant's taste acuity

Group	Value	95% CI
Baseline - Radiotherapy	1.0833333	± 1.1000659
Baseline - Radiotherapy + Cisplatin	0.9090909	± 0.8312094
1 Month - Radiotherapy	2.1363636	± 1.0821255
1 Month - Radiotherapy + Cisplatin	2.9090909	± 1.0444659
6 Months - Radiotherapy	0.9285714	± 0.7300459
6 Months - Radiotherapy + Cisplatin	2.4285714	± 0.9759001
12 Months - Radiotherapy	1.0000000	± 0.7559289
12 Months - Radiotherapy + Cisplatin	1.5714286	± 0.7867958

Change in Quality of Life as Measured by Speech Handicap Index Secondary · Baseline and 12 months

* 31 questions regarding participant's speech and the effects of speech on his/her life * The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4 * The higher the score the worse the participant's speech is affecting his/her life

My speech makes it difficult for people to understand me

Group	Value	95% CI
Baseline - Radiotherapy	1.9565217	± 1.0215078
Baseline - Radiotherapy + Cisplatin	1.7272727	± 0.9045340
12 Months - Radiotherapy	1.3333333	± 0.6172134
12 Months - Radiotherapy + Cisplatin	1.8333333	± 1.3291601

I run out of air when I speak

Group	Value	95% CI
Baseline - Radiotherapy	1.5000000	± 0.7223151
Baseline - Radiotherapy + Cisplatin	1.4545455	± 0.6875517
12 Months - Radiotherapy	1.2666667	± 0.7037316
12 Months - Radiotherapy + Cisplatin	1.8333333	± 1.3291601

The intelligibility of my speech varies throughout the day

Group	Value	95% CI
Baseline - Radiotherapy	2.0000000	± 1.0632191
Baseline - Radiotherapy + Cisplatin	1.5454545	± 0.8201995
12 Months - Radiotherapy	1.4000000	± 0.7367884
12 Months - Radiotherapy + Cisplatin	1.8333333	± 1.3291601

My speech makes me feel incompetent

Group	Value	95% CI
Baseline - Radiotherapy	1.3750000	± 0.6468990
Baseline - Radiotherapy + Cisplatin	1.2727273	± 0.6466698
12 Months - Radiotherapy	1.1333333	± 0.3518658
12 Months - Radiotherapy + Cisplatin	1.5000000	± 0.8366600

People ask me why I'm hard to understand

Group	Value	95% CI
Baseline - Radiotherapy	1.2916667	± 0.6240935
Baseline - Radiotherapy + Cisplatin	1.1818182	± 0.4045199
12 Months - Radiotherapy	1.1333333	± 0.3518658
12 Months - Radiotherapy + Cisplatin	1.3333333	± 0.5163978

I feel annoyed when people ask me to repeat

Group	Value	95% CI
Baseline - Radiotherapy	1.3750000	± 0.8242256
Baseline - Radiotherapy + Cisplatin	1.2727273	± 0.6466698
12 Months - Radiotherapy	1.3333333	± 0.4879500
12 Months - Radiotherapy + Cisplatin	1.6666667	± 1.0327956

I avoid using the phone

Group	Value	95% CI
Baseline - Radiotherapy	1.6250000	± 1.2091139
Baseline - Radiotherapy + Cisplatin	1.5454545	± 0.9341987
12 Months - Radiotherapy	1.1333333	± 0.3518658
12 Months - Radiotherapy + Cisplatin	1.6666667	± 1.0327956

I'm tense when talking to others because of my speech

Group	Value	95% CI
Baseline - Radiotherapy	1.4166667	± 0.7172815
Baseline - Radiotherapy + Cisplatin	1.5454545	± 0.8201995
12 Months - Radiotherapy	1.0666667	± 0.2581989
12 Months - Radiotherapy + Cisplatin	1.6666667	± 1.0327956

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Radiotherapy

Serious: 0/27 (0%)

Deaths: 1/27

Radiotherapy, Cisplatin

Serious: 1/11 (9%)

Deaths: 0/11

Serious adverse events (3 terms)

Reaction	System	Radiotherapy	Radiotherapy, Cisplatin
Xerostomia	Gastrointestinal disorders	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (85 terms — click to expand)

Reaction	System	Radiotherapy	Radiotherapy, Cisplatin
Dermatitis radiation	Injury, poisoning and procedural complications	—	—
Dysgeusia	Nervous system disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Mucositis oral	Gastrointestinal disorders	—	—
Lymphocyte count decreased	Investigations	—	—
White blood cell decreased	Investigations	—	—
Anemia	Blood and lymphatic system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Platelet count decreased	Investigations	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Neutrophil count decreased	Investigations	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
Headache	Nervous system disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Odynophagia	Gastrointestinal disorders	—	—
Salivary duct inflammation	Gastrointestinal disorders	—	—
Oral thrush	Infections and infestations	—	—
Weight loss	Investigations	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Pain - oropharynx	General disorders	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Trismus	Musculoskeletal and connective tissue disorders	—	—
Insomnia	Psychiatric disorders	—	—
Ear pain	Ear and labyrinth disorders	—	—
Middle ear inflammation	Ear and labyrinth disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Localized edema	General disorders	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Dysarthria	Nervous system disorders	—	—

Most-reported serious reactions: Xerostomia, Anorexia, Pulmonary embolism.

Data from ClinicalTrials.gov NCT01687413 adverse events section.

Sponsor's own description

This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways. After the surgery, receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Treatment de-escalation for HPV-driven oropharyngeal cancer: Where do we stand?
Mirghani H, Blanchard P. · · 2018 · cited 120× · PMID 29594236 · DOI 10.1016/j.ctro.2017.10.005
Transoral Endoscopic Head and Neck Surgery and Its Role Within the Multidisciplinary Treatment Paradigm of Oropharynx Cancer: Robotics, Lasers, and Clinical Trials.
Holsinger FC, Ferris RL. · · 2015 · cited 114× · PMID 26351337 · DOI 10.1200/jco.2015.62.3157
Human Papillomavirus-Associated Oropharyngeal Cancer: Defining Risk Groups and Clinical Trials.
Bhatia A, Burtness B. · · 2015 · cited 94× · PMID 26351343 · DOI 10.1200/jco.2015.61.2358
Treatment de-intensification strategies for head and neck cancer.
Kelly JR, Husain ZA, Burtness B. · · 2016 · cited 84× · PMID 27755996 · DOI 10.1016/j.ejca.2016.09.006
Optimizing Treatment De-Escalation in Head and Neck Cancer: Current and Future Perspectives.
Rosenberg AJ, Vokes EE. · · 2021 · cited 80× · PMID 32864799 · DOI 10.1634/theoncologist.2020-0303
Review of the clinical and biologic aspects of human papillomavirus-positive squamous cell carcinomas of the head and neck.
Blitzer GC, Smith MA, Harris SL, Kimple RJ. · · 2014 · cited 78× · PMID 24606845 · DOI 10.1016/j.ijrobp.2013.08.029
The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck.
Psyrri A, Rampias T, Vermorken JB. · · 2014 · cited 59× · PMID 25057165 · DOI 10.1093/annonc/mdu265
Deintensification of treatment for human papillomavirus-related oropharyngeal cancer: Current state and future directions.
Bigelow EO, Seiwert TY, Fakhry C. · · 2020 · cited 55× · PMID 32247987 · DOI 10.1016/j.oraloncology.2020.104652

Verify or expand the search:

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Trials testing the same drug.

NCT06501911 — A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma · Phase 1 · withdrawn
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Currently open trials in the same condition.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01687413 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 25 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01687413.

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