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

Launched by AMERICAN COLLEGE OF RADIOLOGY · Sep 12, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new way to give radiation therapy to patients who have had surgery for intermediate-risk head and neck cancer. The study is exploring whether a standard dose of radiation can be safely delivered in a shorter amount of time, which could make treatment more convenient for patients. Participants in this trial will be those aged 18 to 80 who have been diagnosed with specific types of squamous cell carcinoma in the oral cavity, oropharynx, or larynx, and who have had their cancer completely removed during surgery.

To be eligible, patients must not have any remaining cancer after surgery and should meet certain health criteria, such as having specific types of cancer characteristics that indicate they may benefit from post-surgery radiation. If you join the trial, you'll be monitored closely to ensure your safety throughout the treatment. This study is currently recruiting participants, and it aims to provide valuable information that could improve future cancer treatments for people with head and neck cancers.

Gender

ALL

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.