Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer

NCT05540899 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: ACR 3518
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.

Conditions

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Larynx; Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma of the Oral Cavity

Outcome Measures

Primary Outcomes (1)

• Dose-Limiting Toxicity (DLT)

  All grades are based on Common Terminology Criteria for Adverse Events (CTCAE v.5). H-PORT in this population will be deemed safe if 0-2 patients out of the first 12 evaluable patients experience DLTs. Should 3 or more patients experience DLTs at any time point during the DLT evaluation period, then accrual to the trial will be stopped, if applicable. Once 12 evaluable eligible patients have completed their DLT assessment, the rate of unacceptable DLTs and 95% confidence interval will be summarized using proportions for binary outcomes and the exact binomial method.

  From the start of H-PORT up 12 months post-radiation

Secondary Outcomes (3)

• Incidence of Adverse Events

  From the start of H-PORT up to 12 months post-radiation

• Rate of radiation interruptions

  From the start to the end of H-PORT, assessed up to 4 weeks

• Rate of radiation discontinuations

  From the start to the end of H-PORT, assessed up to 4 weeks

Study Arms (1)

Hypofractionated Postoperative Radiotherapy (H-PORT)

EXPERIMENTAL

H-PORT of 50 Gy given over 4 weeks.

Radiation: Hypofractionated Postoperative Radiotherapy

Interventions

Hypofractionated Postoperative Radiotherapy RADIATION

Hypofractionated Postoperative Radiation Therapy

Also known as: H-PORT

Hypofractionated Postoperative Radiotherapy (H-PORT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx); Note: Hypopharynx primaries are excluded because these patients have both a poor prognosis and high likelihood of post- radiation complications.
• Clinical stage I-IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
• General history and physical examination prior to registration;
• Chest X-ray (at a minimum) or chest CT scan (with or without contrast) or PET/CT of chest (with or without contrast) prior to registration.
• Total resection of the patient's cancer (i.e. no residual disease after total resection of the patient's cancer).
• One or more indications for postoperative radiotherapy, based upon pathologic findings:
• Perineural invasion;
• Lymphovascular invasion;
• Single lymph node ≥ 3 cm or ≥ 2 lymph nodes (no extracapsular Extension);
• Close margin(s) of resection (close margins defined as cancer extending to within 5 mm of a surgical margin);
• Pathologically confirmed T3 or T4a primary tumor;
• T2 oral cavity cancer with ≥ 5 mm depth of invasion.
• Zubrod Performance Status 0-1.
• Age 18-80.
• Negative pregnancy test within 14 days prior to registration for participants who may become pregnant.

You may not qualify if:

• Recurrence of the study cancer.
• History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
• Pregnancy and individuals unwilling to discontinue nursing.
• Reliant on a feeding tube (gastric or jejuno) to maintain adequate nutrition at the time of registration
• Anticipated need for high-dose systemic chemotherapy (e.g., high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; prior chemotherapy for study cancer is not allowed.
• Per the operative and/or pathology report, positive margin(s) \[defined as tumor present at the cut or inked edge of the tumor\], nodal extracapsular extension, and/or gross residual disease after surgery; Note: Patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible.

Sponsors & Collaborators

• American College of Radiology: lead
• RTOG Foundation, Inc.: collaborator

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

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

Study Officials

• Etta Pisano, MD

  American College of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 15, 2022
• Study Start: November 8, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)