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

NCT ID: NCT05540899

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2028-11-30

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine if a hypofractionated postoperative radiotherapy (H-PORT) schedule for patients with intermediate-risk head and neck cancer (squamous cell carcinoma of the oral cavity, oropharynx, or larynx) who have undergone surgery is safe and feasible for further evaluation in a phase II clinical trial.

SECONDARY OBJECTIVES:

I. To assess H-PORT treatment-related and unrelated adverse events during treatment and within one year after treatment completion.

II. To assess H-PORT tolerability and compliance, as measured by treatment interruptions and discontinuations, and to assess the reasons for those modifications.

ARM I: Patients undergo surgery per standard of care followed by hypofractionated radiotherapy. Patients receive 50 Gy over 4 weeks (i.e., 2.5 Gy per day x 20 fractions). Radiation therapy should start after there is adequate healing and no evidence of gross residual/recurrent cancer.

Patients are followed up at 1 month, 3 months, 6 months and 12 months post H-PORT therapy.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated Postoperative Radiotherapy (H-PORT)

H-PORT of 50 Gy given over 4 weeks.

Group Type: EXPERIMENTAL

Hypofractionated Postoperative Radiotherapy

Intervention Type: RADIATION

Hypofractionated Postoperative Radiation Therapy

Interventions

Hypofractionated Postoperative Radiotherapy

Hypofractionated Postoperative Radiation Therapy

Intervention Type: RADIATION

Other Intervention Names

H-PORT

Eligibility Criteria

Inclusion Criteria

• 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.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety assessment of the investigational regimen are eligible for this trial.
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RTOG Foundation, Inc.

OTHER

Sponsor Role: collaborator

American College of Radiology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etta Pisano, MD

Role: PRINCIPAL_INVESTIGATOR

American College of Radiology

Locations

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

ACR 3518

Identifier Type: -

Identifier Source: org_study_id