HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer

NCT04403620 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: STU-2020-0522
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionation for Phase 2. Phase 2 aims to establish non-inferiority of swallowing-related quality of life and to assess the toxicity and efficacy of hypofractionated radiation therapy compared to conventionally fractionated radiation therapy in the post-operative setting.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Radiation Dose Hypofractionation; Adjuvant Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Phase 1: Maximally tolerated dose of hypofractionated radiation therapy

  Dose and fractionation to be used for Phase 2

  3 months

• Phase 2: Swallowing-related patient-reported quality of life

  MD Anderson Dysphagia Inventory (MDADI) composite score: 20-100, higher scores mean better quality of life

  12 months

Secondary Outcomes (9)

• Clinician-reported acute toxicities

  1-3 months

• Clinician-reported late toxicities

  6-24 months

• Locoregional control

  12-24 months

• Progression free survival

  12-24 months

• Swallowing-related patient-reported quality of life

  1-24 months

Study Arms (2)

Conventionally fractionated radiotherapy

ACTIVE COMPARATOR

60 Gy in 30 fractions, 5 fractions/week

Radiation: Intensity-modulated Radiation Therapy (IMRT)

Hypofractionated radiotherapy

EXPERIMENTAL

Dose and fractionation determined by Phase I: Level 1: 44.4 Gy in 12 fractions, 4 fractions/week Level 0: 46.5 Gy in 15 fractions, 5 fractions/week Level -1: 52 Gy in 20 fractions, 5 fractions/week Level -2: 50 Gy in 20 fractions, 5 fractions/week

Radiation: Intensity-modulated Radiation Therapy (IMRT)

Interventions

Intensity-modulated Radiation Therapy (IMRT) RADIATION

Patients will receive adjuvant radiation therapy using intensity-modulated radiation therapy (IMRT) within 8 weeks of surgical resection

Conventionally fractionated radiotherapy; Hypofractionated radiotherapy

Eligibility Criteria

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

You may qualify if:

• Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx status post gross total resection with pathology showing one or more of the following intermediate risk factors:
• T3/4 disease (AJCC 8th edition), positive lymph node(s), close margin(s), perineural invasion, and/or lymphovascular invasion
• Close margin(s) defined as either:
• Final patient margin of \<5 mm without disease on ink OR
• Initial positive margin in the specimen regardless of the final patient margin (e.g. if resection margin on the initial specimen is positive, final patient margin after subsequent resections can be ≥5 mm and still be considered close margin)
• Age ≥18 years
• ECOG performance status 0-2
• 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.
• Medically acceptable birth control (contraceptives) includes:
• approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or
• barrier methods (such as condom or diaphragm) used with a spermicide
• 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, 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).

You may not qualify if:

• Phase I:
• Distant metastasis
• Stage I and II glottic squamous cell carcinoma
• High risk factors following surgical resection requiring concurrent chemotherapy: final positive margin(s) and/or extranodal extension
• Feeding tube dependence at baseline assessment.
• Synchronous non-skin cancer primaries outside of the oropharynx, oral cavity, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer. For prostate cancer, patient should not be receiving active treatment. For thyroid cancer, thyroid surgery may occur before or after 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.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant
• Phase II:

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Dominic Moon, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Dose/fractionation finding Phase 1 study, followed by a randomized Phase 2 study

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 27, 2020
• Study Start: July 28, 2020
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)