NCT02641691 (NORMAL-R) is a Phase 2 clinical trial of Radiation in Cancer of Rectum, sponsored by Washington University School of Medicine.

Who is sponsoring NCT02641691?

NCT02641691 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT02641691?

Interventions in NCT02641691: Radiation, Oxaliplatin, Leucovorin, Fluorouracil.

What condition does NCT02641691 study?

NCT02641691 studies Cancer of Rectum, Cancer of the Rectum, Neoplasm, Rectum, Rectal Cancer, Rectum Cancer, Rectum Neoplasms, Adenocarcinoma of the Rectum.

Is NCT02641691 still recruiting?

NCT02641691 is currently completed. Last updated 18 February 2021.

Are results published for NCT02641691?

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

Last reviewed 2021-02-18 · How we verify

NCT02641691: NORMAL-R

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

Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum

Completed Phase 2 Results posted Last updated 18 February 2021

What this trial tests

Phase 2 trial testing Radiation in Cancer of Rectum in 20 participants. Completed in 29 March 2020.

Timeline

27 May 2016

Primary endpoint
4 February 2020

29 March 2020

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	27 May 2016
Primary completion	4 February 2020
Estimated completion	29 March 2020
Sites	1 location across United States

Drugs / interventions tested

Radiation
Oxaliplatin (Oxaliplatin) — full drug profile →
Leucovorin (leucovorin) — full drug profile →
Fluorouracil — full drug profile →

Conditions studied

Cancer of Rectum — all drugs for Cancer of Rectum →
Cancer of the Rectum — all drugs for Cancer of the Rectum →
Neoplasm, Rectum — all drugs for Neoplasm, Rectum →
Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Cancer of Rectum or Cancer of the Rectum. 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.

Complete Response Rate Primary · 1 year

* Criteria for complete clinical response: * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer * No radiographic evidence of tumor on DRE * Substantial downsizing on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) * Criteria for no significant clinical response: * Residual disease by DRE, endoscopy or MR. * Increase in primary tumor size upon clinical exam or imaging * Any new lesions

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	12

Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire Secondary · Baseline

-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

I have a lack of energy

Group	Value	95% CI
0=Not at All	9
1=A Little Bit	3
2=Somewhat	6
3=Quite a Bit	2
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I have nausea

Group	Value	95% CI
0=Not at All	19
1=A Little Bit	0
2=Somewhat	1
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

Because of my physical condition, I have trouble meeting the needs of my family

Group	Value	95% CI
0=Not at All	17
1=A Little Bit	2
2=Somewhat	1
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I have pain

Group	Value	95% CI
0=Not at All	11
1=A Little Bit	6
2=Somewhat	2
3=Quite a Bit	1
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I am bothered by side effects of treatment

Group	Value	95% CI
0=Not at All	19
1=A Little Bit	0
2=Somewhat	0
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	1

I feel ill

Group	Value	95% CI
0=Not at All	19
1=A Little Bit	0
2=Somewhat	1
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I am forced to spend time in bed

Group	Value	95% CI
0=Not at All	17
1=A Little Bit	1
2=Somewhat	1
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	1

I feel close to my friends

Group	Value	95% CI
0=Not at All	0
1=A Little Bit	0
2=Somewhat	1
3=Quite a Bit	1
4=Very Much	18
Prefer Not to Answer/No Answer/No	0

Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire Secondary · Completion of chemoradiation (approximately 112 days)

-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

I have a lack of energy

Group	Value	95% CI
0=Not at All	3
1=A Little Bit	3
2=Somewhat	11
3=Quite a Bit	2
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I have nausea

Group	Value	95% CI
0=Not at All	16
1=A Little Bit	3
2=Somewhat	0
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

Because of my physical condition, I have trouble meeting the needs of my family

Group	Value	95% CI
0=Not at All	8
1=A Little Bit	8
2=Somewhat	2
3=Quite a Bit	0
4=Very Much	1
Prefer Not to Answer/No Answer/No	0

I have pain

Group	Value	95% CI
0=Not at All	11
1=A Little Bit	3
2=Somewhat	4
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	1

I am bothered by side effects of treatment

Group	Value	95% CI
0=Not at All	6
1=A Little Bit	7
2=Somewhat	3
3=Quite a Bit	2
4=Very Much	1
Prefer Not to Answer/No Answer/No	0

I feel ill

Group	Value	95% CI
0=Not at All	16
1=A Little Bit	2
2=Somewhat	0
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	1

I am forced to spend time in bed

Group	Value	95% CI
0=Not at All	13
1=A Little Bit	6
2=Somewhat	0
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I feel close to my friends

Group	Value	95% CI
0=Not at All	0
1=A Little Bit	1
2=Somewhat	1
3=Quite a Bit	3
4=Very Much	14
Prefer Not to Answer/No Answer/No	0

Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire Secondary · 10-14 months after chemoradiation (approximately 16-20 months)

-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

I have a lack of energy

Group	Value	95% CI
0=Not at All	4
1=A Little Bit	5
2=Somewhat	5
3=Quite a Bit	4
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I have nausea

Group	Value	95% CI
0=Not at All	17
1=A Little Bit	0
2=Somewhat	1
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

Because of my physical condition, I have trouble meeting the needs of my family

Group	Value	95% CI
0=Not at All	10
1=A Little Bit	4
2=Somewhat	4
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I have pain

Group	Value	95% CI
0=Not at All	9
1=A Little Bit	5
2=Somewhat	3
3=Quite a Bit	0
4=Very Much	1
Prefer Not to Answer/No Answer/No	0

I am bothered by side effects of treatment

Group	Value	95% CI
0=Not at All	5
1=A Little Bit	2
2=Somewhat	6
3=Quite a Bit	3
4=Very Much	2
Prefer Not to Answer/No Answer/No	0

I feel ill

Group	Value	95% CI
0=Not at All	15
1=A Little Bit	2
2=Somewhat	1
3=Quite a Bit	0
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I am forced to spend time in bed

Group	Value	95% CI
0=Not at All	14
1=A Little Bit	2
2=Somewhat	1
3=Quite a Bit	1
4=Very Much	0
Prefer Not to Answer/No Answer/No	0

I feel close to my friends

Group	Value	95% CI
0=Not at All	0
1=A Little Bit	0
2=Somewhat	2
3=Quite a Bit	4
4=Very Much	12
Prefer Not to Answer/No Answer/No	0

Number of Any Grade 3 or Higher Toxicities Secondary · From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks)

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Anemia

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	2

Febrile neutropenia

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	2

Cardiac arrest

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	1

Myocardial infarction

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	1

Ventricular fibrillation

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	1

Abdominal pain

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	1

Diarrhea

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	3

Pancreatitis

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	1

Number of Post Chemotherapy Grade 3 or Higher Toxicities Secondary · Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months)

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Anemia

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	2

Febrile neutropenia

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	2

Cardiac arrest

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	1

Myocardial infarction

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	1

Ventricular fibrillation

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	1

Abdominal pain

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	1

Diarrhea

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	3

Fever

Group	Value	95% CI
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	2

Quality of Anorectal Function as Measured by the FACT-C Questionnaire Secondary · Baseline

-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

I have control of my bowels

Group	Value	95% CI
0=Not at All	1
1=A Little Bit	0
2=Somewhat	5
3=Quite a Bit	3
4=Very Much	11

I have diarrhea (diarrhoea)

Group	Value	95% CI
0=Not at All	9
1=A Little Bit	5
2=Somewhat	4
3=Quite a Bit	0
4=Very Much	2

Quality of Anorectal Function as Measured by the FACT-C Questionnaire Secondary · Completion of chemoradiation (approximately 112 days)

-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

I have control of my bowels

Group	Value	95% CI
0=Not at All	1
1=A Little Bit	4
2=Somewhat	6
3=Quite a Bit	4
4=Very Much	4

I have diarrhea (diarrhoea)

Group	Value	95% CI
0=Not at All	4
1=A Little Bit	10
2=Somewhat	2
3=Quite a Bit	2
4=Very Much	1

Quality of Anorectal Function as Measured by the FACT-C Questionnaire Secondary · 10-14 months after chemoradiation (approximately 16-20 months)

-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

I have control of my bowels

Group	Value	95% CI
0=Not at All	2
1=A Little Bit	2
2=Somewhat	7
3=Quite a Bit	5
4=Very Much	2

I have diarrhea (diarrhoea)

Group	Value	95% CI
0=Not at All	6
1=A Little Bit	6
2=Somewhat	2
3=Quite a Bit	2
4=Very Much	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU

Serious: 8/20 (40%)

Deaths: 1/20

Serious adverse events (11 terms)

Reaction	System	Arm 1: Radiation/Oxaliplat…
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Hypotension	Vascular disorders	—
Dehydration	Metabolism and nutrition disorders	—
Myocardial infarction	Cardiac disorders	—
Cardiac arrest	Cardiac disorders	—
Syncope	Nervous system disorders	—
Lung infection	Infections and infestations	—
Febrile neutropenia	Blood and lymphatic system disorders	—
Thromboembolic event	Vascular disorders	—
Pancreatitis	Gastrointestinal disorders	—
Fall	Injury, poisoning and procedural complications	—

Other adverse events (47 terms — click to expand)

Reaction	System	Arm 1: Radiation/Oxaliplat…
Peripheral sensory neuropathy	Nervous system disorders	—
Diarrhea	Gastrointestinal disorders	—
Neutrophil count decreased	Investigations	—
Fatigue	General disorders	—
Anemia	Blood and lymphatic system disorders	—
Lymphocyte count decreased	Investigations	—
White blood cell decreased	Investigations	—
Hyponatremia	Metabolism and nutrition disorders	—
Abdominal pain	Gastrointestinal disorders	—
Hypokalemia	Metabolism and nutrition disorders	—
Anxiety	Psychiatric disorders	—
Insomnia	Psychiatric disorders	—
Febrile neutropenia	Blood and lymphatic system disorders	—
Ventricular fibrillation	Cardiac disorders	—
Constipation	Gastrointestinal disorders	—
Mucositis oral	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Rectal pain	Gastrointestinal disorders	—
Fever	General disorders	—
Cholecystitis	Hepatobiliary disorders	—
Activated partial thromboplastin time prolonged	Investigations	—
Aspartate aminotransferase	Investigations	—
Cardiac troponin I increased	Investigations	—
Cardiac troponin T increased	Investigations	—
Platelet count decreased	Investigations	—
Anorexia	Metabolism and nutrition disorders	—
Dehydration	Metabolism and nutrition disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—
Hypoalbuminemia	Metabolism and nutrition disorders	—
Leg pain	Musculoskeletal and connective tissue disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Generalized muscle weakness	General disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Peripheral sensory neuropathy	Nervous system disorders	—
Cold sensitivity	Nervous system disorders	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Hematuria	Renal and urinary disorders	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Aspiration	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Dyspnea, Hypotension, Dehydration, Myocardial infarction, Cardiac arrest, Syncope, Lung infection, Febrile neutropenia.

Data from ClinicalTrials.gov NCT02641691 adverse events section.

Sponsor's own description

The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Nonoperative Rectal Cancer Management With Short-Course Radiation Followed by Chemotherapy: A Nonrandomized Control Trial.
Kim H, Pedersen K, Olsen JR, Mutch MG, et al · · 2021 · cited 31× · PMID 34001462 · DOI 10.1016/j.clcc.2021.03.003

Verify or expand the search:

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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 NCT02641691 (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: 18 February 2021

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/NCT02641691.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02641691: NORMAL-R

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (11 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Radiation

Other recruiting trials for Cancer of Rectum

Other Washington University School of Medicine trials

Verify against primary sources