Reduced Radiation + Chemotherapy for Oral Squamous Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen byNancy Lee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation. Accrual for Cohort A has been completed. Cohort B is active and continues to enroll participants where surgery is optional and proton is allowed.

Eligibility Criteria

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.

Inclusion Criteria

My kidney function is good, based on recent tests.

Bilirubin ≤ 2 mg/dl

AST or ALT ≤ 3 x the upper limit of normal

+25 more

Exclusion Criteria

I might have other primary cancers, but the lead researcher agrees I can join.

I've been cancer-free for 3 years, except for non-dangerous skin cancers.

I have not undergone particle therapy like proton therapy for my condition in Cohort A.

+9 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Arm B: HPV associated oropharyngeal carcinomaExperimental Treatment6 Interventions

HPV associated oropharyngeal carcinoma subjects who also have no evidence of hypoxia.

Group II: Arm A: HPV associated oropharyngeal carcinomaExperimental Treatment5 Interventions

HPV associated oropharyngeal carcinoma subjects who also have no evidence of hypoxia. This arm is closed to accrual.