Major De-escalation to 30 Gy for Select Human Papillomavirus Associated Oropharyngeal Carcinoma

Phase 2 Active not recruiting 316 enrolled Memorial Sloan Kettering Cancer Center

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2017-10-16
Primary completion: 2026-10-31
Completion: 2026-10-31

Outcome

Met primary endpoint

paper The 2-year LRC was 94.7% (95% CI, 89.8 to 97.7), meeting our primary objective. PMID 38241600 ↗

Publications

Lee NY, Sherman EJ, Schoder H, Wray R, Boyle JO, Singh B, Grkovski M, Paudyal R, Cunningham L, Zhang Z, Hatzoglou V, Katabi N, Diplas BH, Han J, Imber BS, Pham K, Yu Y, Zakeri K, McBride SM, Kang JJ, Tsai CJ, Chen LC, Gelblum DY, Shah JP, Ganly I, Cohen MA, Cracchiolo JR, Morris LGT, Dunn LA, Michel LS, Fetten JV, Kripani A, Pfister DG, Ho AL, Shukla-Dave A, Humm JL, Powell SN, Li BT, Reis-Filho JS, Diaz LA, Wong RJ, Riaz N. Hypoxia-Directed Treatment of Human Papillomavirus-Related Oropharyngeal Carcinoma. J Clin Oncol. 2024 Mar 10;42(8):940-950. doi: 10.1200/JCO.23.01308. Epub 2024 Jan 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	1.25 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	100 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	600 mg/m2	Intravenous