Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patie… (NCT05540899) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
United States14 participantsStarted 2023-11-08
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 m…
What they're measuring
1
Dose-Limiting Toxicity (DLT)
Timeframe: From the start of H-PORT up 12 months post-radiation