RecruitingPhase 2NCT06984861

A Study of Reduced Radiation Therapy With Chemotherapy in People With HPV-Positive Throat Cancer

Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Advanced Stage Human Papilloma Virus Associated Oropharyngeal Carcinoma

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

74 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

Oropharyngeal Carcinoma

Summary

The researchers are doing this study is to find out if lower doses (given in fewer treatments over a shorter period of time) of radiation therapy in combination with standard-of-care chemotherapy is an effective treatment for people with Human Papilloma Virus (HPV)-positive throat cancer and works as well as the standard doses of radiation therapy in combination with standard-of-care chemotherapy. The chemotherapy drugs used in combination with radiation therapy in this study include cisplatin, carboplatin, and 5-fluorouracil (5-FU).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people with HPV-related throat cancer can receive a lower dose of radiation alongside chemotherapy and still have good outcomes — with the goal of reducing long-term side effects from radiation. **You may be eligible if...** - You have been diagnosed with HPV-positive squamous cell carcinoma of the throat (tonsil, base of tongue, or throat walls) - You tested positive for HPV (specifically p16 expression) - Your cancer has been confirmed by biopsy or surgical removal **You may NOT be eligible if...** - You do not have HPV-positive throat cancer - You have not had a tissue biopsy or core biopsy to confirm the diagnosis - Your cancer is located outside the qualifying throat regions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST18F-FMISO PET/CT Scan

The 18F-FMISO PET/CT Scan Protocol consists first of an IV bolus injection of approximately 5-10 mCi of the radiotracer. Subjects will undergo 18F-FMISO scan (only 1 injection) occurs at 8-10 treatment days\* into chemoradiation. Each patient will have a baseline staging FDG PET scan which is used to localize the tumor at the primary site and all suspicious cervical neck nodes (\> 1 cm in short axis diameter with focal abnormal increased FDG avidity). These lesions are then assessed on the respective 18F-FMISO PET/CT.

COMBINATION_PRODUCTChemoradiation

Patients will start with induction chemotherapy of carboplatin, paclitaxel and cetuximab for 6 weeks and when downstaged to T1-2 and \< N3, the patient is eligible to receive concurrent chemoradiation per protocol. All subjects will undergo radiation treatments (IMRT and/or proton therapy). A total radiation therapy of 30Gy will be delivered to the oropharynx and neck at 2Gy per fraction per day over 15 days for patients who exhibited no evidence of hypoxia on the intra-treatment 18F-FMISO PET/CT. Concurrent chemotherapy (2 cycles) will be given. After completion of chemotherapy and radiation therapy, a 4 month (+/-4 weeks)

OTHERQuestionnaires

EQ-5D-5L, MDADI-HN, COST-FACIT