Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer

Summary

This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.

Timeline

Start

2014-10

Primary completion

2019-06-10

Completion

2025-09-04

Outcome

Mixed primary results

paper Two-year PFS for IMRT + C was 90.5% rejecting the null hypothesis of 2-year PFS ≤ 85% (P = .04). PMID 33507809 ↗

paper For IMRT, 2-year PFS was 87.6% (P = .23). PMID 33507809 ↗

Publications

• Yom SS, Torres-Saavedra P, Caudell JJ, Waldron JN, Gillison ML, Xia P, Truong MT, Kong C, Jordan R, Subramaniam RM, Yao M, Chung CH, Geiger JL, Chan JW, O'Sullivan B, Blakaj DM, Mell LK, Thorstad WL, Jones CU, Banerjee RN, Lominska C, Le QT. Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002). J Clin Oncol. 2021 Mar 20;39(9):956-965. doi: 10.1200/JCO.20.03128. Epub 2021 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	40 mg/m2	Intravenous

Indications