Who is sponsoring NCT04580446?

NCT04580446 is sponsored by University of Texas Southwestern Medical Center.

What drugs are being tested in NCT04580446?

Interventions in NCT04580446: Hypofractionated intensity modulated radiotherapy.

What condition does NCT04580446 study?

NCT04580446 studies Human Papillomavirus-Related Carcinoma, Oropharyngeal Cancer.

Is NCT04580446 still recruiting?

NCT04580446 is currently completed. Last updated 15 December 2025.

Are results published for NCT04580446?

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

Last reviewed 2025-12-15 · How we verify

NCT04580446

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

HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer

Completed Phase 1 Results posted Last updated 15 December 2025

What this trial tests

Phase 1 trial testing Hypofractionated intensity modulated radiotherapy in Human Papillomavirus-Related Carcinoma in 24 participants. Completed in 20 December 2024.

Timeline

3 December 2020

Primary endpoint
20 December 2024

20 December 2024

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	3 December 2020
Primary completion	20 December 2024
Estimated completion	20 December 2024
Sites	1 location across United States

Drugs / interventions tested

Hypofractionated intensity modulated radiotherapy

Conditions studied

Human Papillomavirus-Related Carcinoma — all drugs for Human Papillomavirus-Related Carcinoma →
Oropharyngeal Cancer — all drugs for Oropharyngeal Cancer →

Sponsor

University of Texas Southwestern Medical Center

Who can join

18 and older, any sex, with Human Papillomavirus-Related Carcinoma or Oropharyngeal Cancer. 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.

Maximally Tolerated Dose/Fractionation of Hypofractionated Radiation Therapy Primary · 3 months

The number of participants experiencing dose-limiting toxicities (DLTs) will be used to determine the maximally tolerated dose (MTD) or optimal fractionation of hypofractionated radiation therapy. Level 0: 46.5 Gy in 15 fractions Level -1: 52 Gy in 20 fractions

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	0

Clinician-reported Acute Toxicities Secondary · 0-3 months

Toxicities as measured by CTCAE v5.0

Odynophagia/sore throat (grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)	18

Oral mucositis (grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)	15

Weight loss/anorexia (grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)	13

Dysphagia ( grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)	11

Dysgeusia (grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)	9

Xerostomia (grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)	7

Nausea/vomiting (grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)	2

Odynophagia/sore throat (grade 3)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)	1

Clinician-reported Late Toxicities Secondary · 3-12 months

As measured by CTCAE v5.0

Dysphagia (grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	1

Weight loss/anorexia (grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	1

Xerostomia (grade 2)

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	1

Grade 3 AE

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	0

Grade 4 AE

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	0

Grade 5 AE

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	0

Percentage of Participants With Locoregional Control Secondary · 12 months

Locoregional control defined as freedom from locoregional recurrence. Locoregional recurrence defined as biopsy-proven viable cancer originating from the primary tumor site (i.e. oropharynx) or a lymph node basin above the clavicles.

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	86.2	68 – 96.8

Percentage of Participants With Progression Free Survival Secondary · 1-12 months

Progression-free survival defined as time from start of treatment to time of progression or death.

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	82	59 – 93

Percentage of Participants With Overall Survival Secondary · 24 months

Overall survival defined as time from start of treatment o time of death.

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	95.8	74 – 99

Swallowing-related Patient-reported Quality of Life Secondary · 1-12 months

Change from baseline in swallowing-related quality of life, as measured by the MD Anderson Dysphagia Inventory (MDADI) total score, assessed at specified time points (baseline,1, 3, 6, and 12 months) during and after treatment. Higher scores indicate better function, 0-100. Analyses were descriptive, and a paired t test was used to compare questionnaire results over time with P \< .05 considered statistically signiﬁcant. MDADI composite score difference of 10 was deemed clinically meaningful.

Baseline

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	86.5	± 13.7

1 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	77.9	± 11.6

3 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	85.5	± 11.3

6 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	87.8	± 12.3

12 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	89.4	± 9.4

Head and Neck Patient-reported Quality of Life Secondary · 1-12 months

Change from baseline in head and neck patient-reported outcomes quality of life, as measured by the University of Washington Quality of Life questionnaire (UW-QOL), assessed at specified time points (baseline,1, 3, 6, and 12 months) during and after treatment. Higher scores on UW-QOL subscales indicate better quality of life, 0 being worst and 100 being the best outcome. A paired t test was used to compare questionnaire results over time with P \< .05 considered statistically signiﬁcant. UW-QOL was divided into 2 subscales of physical and social-emotional function with change of 0.5 x standard

Physical Baseline

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	93.4	± 9.9

Physical 1 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	74.9	± 11.4

Physical 3 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	80.3	± 11.3

Physical 6 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	84.8	± 11.7

Physical 12 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	85.3	± 11.7

Social-Emotional Baseline

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	89.4	± 16.5

Social-Emotional 1 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	79.9	± 10.3

Social-Emotional 3 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	87.6	± 10.0

General Patient-reported Quality of Life Secondary · 1-12 months

EuroQol-5 dimensions (EQ-5D-5L): 1-5, higher scores mean worse quality of life. Index score: 0-1, higher scores mean better quality of life. Visual Analog scale: 0-100, higher scores mean better quality of life.

Index score Enrollment

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	0.916	± 0.163

Index score 1 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	0.879	± 0.107

Index score 3 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	0.909	± 0.120

Index score 6 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	0.915	± 0.166

Index score 12 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	0.933	± 0.103

Visual Analog Scale Enrollment

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	86.8	± 12.4

Visual Analog Scale 1 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	79.1	± 11.5

Visual Analog Scale 3 mo

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	81.9	± 12.0

Feeding Tube Dependence Secondary · 1-12 months

Dependence on tube feeds defined as any participant with daily use of ≥2 nutritional supplements per day via the feeding tube at the time of evaluation.

Acute follow up period

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	2

Late follow up period

Group	Value	95% CI
Hypofractionated radiotherapy with concurrent chemotherapy	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year post radiation treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hypofractionated radiotherapy with concurrent chemotherapy

Serious: 6/24 (25%)

Deaths: 1/24

Serious adverse events (6 terms)

Reaction	System	Hypofractionated radiother…
Thromboembolic event bilateral pulmonary embolism	Vascular disorders	—
Death NOS	General disorders	—
Fever	General disorders	—
Lymphocyte count decreased	Investigations	—
Dysphagia	Gastrointestinal disorders	—
Mucositis oral	Gastrointestinal disorders	—

Other adverse events (183 terms — click to expand)

Reaction	System	Hypofractionated radiother…
Dermatitis radiation	Injury, poisoning and procedural complications	—
Dry mouth	Gastrointestinal disorders	—
Dysgeusia	Nervous system disorders	—
Gastrointestinal disorders - Other, Odynophagia	Gastrointestinal disorders	—
Dysphagia	Gastrointestinal disorders	—
Fatigue	General disorders	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—
Mucositis oral	Gastrointestinal disorders	—
Hypertension	Vascular disorders	—
Nausea	Gastrointestinal disorders	—
Weight loss	Investigations	—
Anorexia	Metabolism and nutrition disorders	—
Constipation	Gastrointestinal disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Allergic rhinitis	Reproductive system and breast disorders	—
Tinnitus	Ear and labyrinth disorders	—
Ear pain	Ear and labyrinth disorders	—
Neck pain	Musculoskeletal and connective tissue disorders	—
Oral Pain	Gastrointestinal disorders	—
Alopecia	Skin and subcutaneous tissue disorders	—
Gastroesophageal reflux disease	Gastrointestinal disorders	—
Hyperlipidemia	Metabolism and nutrition disorders	—
Lymphedema	Vascular disorders	—
Lymphocyte count decreased	Investigations	—
Anxiety	Psychiatric disorders	—
Dizziness	Nervous system disorders	—
Gastrointestinal disorders - Other, Thick secretions	Gastrointestinal disorders	—
Sleep apnea	Respiratory, thoracic and mediastinal disorders	—
Thrush	Infections and infestations	—
Hoarseness	Respiratory, thoracic and mediastinal disorders	—
Infections and infestations - Other, COVID-19	Infections and infestations	—
Insomnia	Psychiatric disorders	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Pain	General disorders	—
Trismus	Musculoskeletal and connective tissue disorders	—
Allergic reaction	Immune system disorders	—
Anemia	Blood and lymphatic system disorders	—
Arthritis	Musculoskeletal and connective tissue disorders	—
Atrial fibrillation	Cardiac disorders	—

Most-reported serious reactions: Thromboembolic event bilateral pulmonary embolism, Death NOS, Fever, Lymphocyte count decreased, Dysphagia, Mucositis oral.

Data from ClinicalTrials.gov NCT04580446 adverse events section.

Sponsor's own description

This is a single arm Phase I study of de-intensified hypofractionated radiation therapy for favorable human papilloma virus-associated oropharynx cancer. It will evaluate the tolerability of a de-intensified hypofractionated radiation therapy regimen completed in 3 weeks (with equivalent biologically effective dose to 60 Gy in 30 fractions) with concurrent weekly cisplatin.

Publications & conference data

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

HPV-associated oropharyngeal cancer: epidemiology, molecular biology and clinical management.
Lechner M, Liu J, Masterson L, Fenton TR. · · 2022 · cited 669× · PMID 35105976 · DOI 10.1038/s41571-022-00603-7
What is the future of treatment de-escalation for HPV-positive oropharyngeal cancer? A review of ongoing clinical trials.
Mensour EA, Alam S, Mawani S, Bahig H, et al · · 2022 · cited 13× · PMID 36620554 · DOI 10.3389/fonc.2022.1067321
Understanding the impact of radiotherapy fractionation on overall survival in a large head and neck squamous cell carcinoma dataset: a comprehensive approach combining mechanistic and machine learning models.
Shuryak I, Wang E, Brenner DJ. · · 2024 · PMID 39193391 · DOI 10.3389/fonc.2024.1422211

Verify or expand the search:

Other recruiting trials for Human Papillomavirus-Related Carcinoma

Currently open trials in the same condition.

NCT07104240 — A Vaccine Promotion Package (TweenVax) to Improve Adolescent HPV Vaccination, TweenVax Trial · NA · recruiting
NCT05985681 — Testing RG1-VLP Vaccine to Prevent HPV-related Cancers · Phase 1 · recruiting
NCT05232851 — A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomaviru · Phase 1, PHASE2 · active not recruiting
NCT03634267 — MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Can · Phase 1 · active not recruiting
NCT03036930 — Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients · Phase 2 · active not recruiting

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

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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 NCT04580446 (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 University of Texas Southwestern Medical Center
Last refreshed: 15 December 2025

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/NCT04580446.

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