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

Trial Title: 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

Condition: 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

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Hypofractionated Postoperative Radiotherapy
Description: Hypofractionated Postoperative Radiation Therapy
Arm group label: Hypofractionated Postoperative Radiotherapy (H-PORT)

Other name: H-PORT

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Milton S. Hershey Medical Center

Address:
City: Hershey
Zip: 17033
Country: United States

Status: Recruiting

Contact:
Last name: Brittany Vogt

Phone: 717-531-0003
Email: bvogt@pennstatehealth.psu.edu

Investigator:
Last name: Mitchell Machtay, MD
Email: Principal Investigator

Start date: November 8, 2023

Completion date: November 2028

Lead sponsor:
Agency: American College of Radiology
Agency class: Other

Collaborator:
Agency: RTOG Foundation, Inc.
Agency class: Other

Source: American College of Radiology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05540899