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Reduced Radiation + Chemotherapy for Oral Squamous Cell Carcinoma

Phase 2

Waitlist Available

Led By Nancy Lee, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function within 30 days prior to registration, defined as follows: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula, CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)], CCr female = 0.85 x (CrCl male)

Subjects must have clinically or radiographically evident measurable disease at nodal stations.

Must not have

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years (+/- 3 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing a less intense radiation therapy with 2 cycles of standard chemotherapy to the current standard chemoradiation for people with HPV positive and hypoxia negative T1-2, N1-2c oropharyngeal squamous cell carcinoma.

Who is the study for?

Adults with HPV-associated oropharyngeal squamous cell carcinoma, stages T1-2 N1-2c, can join this trial. They must have good blood counts, kidney and liver function, and no history of chemotherapy for the cancer being studied. Pregnant women must test negative. Those with prior head/neck radiation or other cancers (except certain skin cancers) within 3 years are excluded.

What is being tested?

The study tests if a reduced radiation dose (30 Gy over 3 weeks) combined with standard chemotherapy is as effective as the current treatment for specific throat cancer patients without oxygen-deficient tumors. Cohort B allows optional surgery and proton therapy.

What are the potential side effects?

Possible side effects include reactions to chemotherapy drugs like Cisplatin or Carboplatin such as nausea, vomiting, kidney damage; Proton Therapy may cause skin redness and sore throat; PET/CT scan has minimal risks but includes exposure to radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is good, based on recent tests.

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My cancer can be measured or seen on scans in my lymph nodes.

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My cancer is in an early stage and hasn't spread far, confirmed by a special scan.

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I can take care of myself but may not be able to do active work.

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I am 18 years old or older.

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I have HPV-related cancer in my throat area confirmed by a biopsy.

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My blood tests meet the required levels for white blood cells, neutrophils, platelets, and hemoglobin.

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I have HPV-related throat cancer confirmed by a biopsy.

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I have HPV-related cancer in my throat area.

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My kidney function is within the normal range.

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My liver tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.

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I am currently on IV antibiotics for a bacterial or fungal infection.

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I haven't been hospitalized for lung problems in the last 30 days.

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I have liver problems causing jaundice or blood clotting issues.

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I have had radiation therapy for head or neck cancer.

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I have cancer in areas other than the oropharynx.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years (+/- 3 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years (+/- 3 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years (+/- 3 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness of study treatment for participants receiving de-escalated radiation therapy radiation therapy, comparable to participants treated with the current standard of care chemoradiation by standard CT (or MRI) or tumor site and PET scan