RecruitingPhase 2NCT05544136

A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer

A Pilot Study of Radiation De-Escalation for p16 Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

12 participants

Start Date

Sep 12, 2022

Study Type

INTERVENTIONAL

Conditions

Head and Neck Carcinoma Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Head and Neck Neoplasms

Summary

The purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether people with certain types of head and neck cancer can safely receive lower doses of radiation and chemotherapy while still getting good outcomes. The goal is to reduce side effects from treatment. **You may be eligible if...** - You have been diagnosed with squamous cell cancer of the head and neck (throat, voice box, or unknown primary site) - Your cancer is at a specific stage (T0–T3, N1–N2C, no distant spread) - You are in good physical condition (ECOG 0–1) - Your cancer has NOT spread to the nose, mouth, salivary glands, or other excluded areas **You may NOT be eligible if...** - Your cancer has already spread to distant parts of the body - Your cancer is at the nasopharynx, oral cavity, or skin - You have previously received radiation to the head and neck area - You are pregnant - Your cancer has a specific genetic marker (p16-positive oropharynx cancer) 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

18F-FMISO PET/CT scan (only 1 injection) that occurs 5-10 treatment days after RT start

RADIATIONChemoradiation therapy

* 18F-FMISO hypoxia negative patients complete CRT with 70Gy primary tumor and 50Gy de-escalated RT dose to gross nodes (if 50Gy is has pilot efficacy, then 44Gy to gross nodes; if 44Gy has pilot efficacy, then 40Gy to gross nodes). * 18F-FMISO hypoxia positive patients are taken off study and complete SOC 70Gy CRT to primary tumor and gross nodes.

DRUGCarboplatin

The chemotherapy used in this protocol is the standard of care for head and neck cancer, cisplatin or carboplatin/5-Fluorouracil

Locations(6)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05544136

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