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

NCT04580446 | Completed Phase 1 Results DMC

• 1 other identifier: STU-2020-1079
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papillomavirus-Related Carcinoma; Oropharyngeal Cancer

Keywords

Radiation Dose Hypofractionation

Outcome Measures

Primary Outcomes (1)

• Maximally Tolerated Dose/Fractionation of Hypofractionated Radiation Therapy

  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

  3 months

Secondary Outcomes (9)

• Clinician-reported Acute Toxicities

  0-3 months

• Clinician-reported Late Toxicities

  3-12 months

• Percentage of Participants With Locoregional Control

  12 months

• Percentage of Participants With Progression Free Survival

  1-12 months

• Percentage of Participants With Overall Survival

  24 months

Study Arms (1)

Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)

EXPERIMENTAL

Level 0: 46.5 Gy in 15 fractions, 5 fractions/week Level -1: 52 Gy in 20 fractions, 5 fractions/week

Radiation: Hypofractionated intensity modulated radiotherapy

Interventions

Hypofractionated intensity modulated radiotherapy RADIATION

Hypofractionated intensity modulated radiotherapy with concurrent chemotherapy (weekly cisplatin)

Hypofractionated radiotherapy with concurrent chemotherapy (weekly cisplatin 40 mg/m2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• ≤10 pack-year smoking history and not actively smoking
• Age ≥18 years
• ECOG performance status 0-2 or Karnofsky Performance Status 50-100
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
• Ability to understand and the willingness to sign a written informed consent.
• Distant metastasis
• T1-2N0 (AJCC 8th edition) p16 positive squamous cell carcinoma of the oropharynx (candidates for definitive RT alone or surgery alone)
• Inability to receive concurrent weekly cisplatin due to comorbid conditions
• Synchronous non-skin cancer primaries outside of the oropharynx, oral cavity, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and well-differentiated thyroid cancer. For prostate cancer, patient should not be receiving active treatment. For thyroid cancer, thyroid surgery may occur before or after radiation treatment, provided all other eligibility criteria are met.
• Prior invasive malignancy with an expected disease-free interval of less than 3 years
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields
• Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Gateway for Cancer Research: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Dominic Moon
• Organization: UT Southwestern Medical Center

Dominic.Moon@UTSouthwestern.edu

214-645-8525

Study Officials

• Dominic Moon, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Rolling 6 dose finding cohort followed by dose expansion cohort

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: December 3, 2020
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-11

Locations

US (1)