Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer

Summary

This randomized phase II trial studies the side effects and how well intensity-modulated radiation therapy (IMRT) and paclitaxel with or without pazopanib hydrochloride works in treating patients with anaplastic thyroid cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, 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. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and paclitaxel are more effective when given with pazopanib hydrochloride in treating thyroid cancer.

Timeline

Start

2010-10-28

Primary completion

2020-03-09

Completion

2022-05-20

Outcome

Missed primary endpoint

registry p = 0.2831; Hazard Ratio (HR) 0.86 (95% CI 0.52 to 1.43); Log Rank NCT01236547 ↗

paper Overall survival was not significantly improved with pazopanib versus placebo PMID 36681089 ↗

Publications

• Sherman EJ, Harris J, Bible KC, Xia P, Ghossein RA, Chung CH, Riaz N, Gunn GB, Foote RL, Yom SS, Wong SJ, Koyfman SA, Dzeda MF, Clump DA, Khan SA, Shah MH, Redmond K, Torres-Saavedra PA, Le QT, Lee NY. Radiotherapy and paclitaxel plus pazopanib or placebo in anaplastic thyroid cancer (NRG/RTOG 0912): a randomised, double-blind, placebo-controlled, multicentre, phase 2 trial. Lancet Oncol. 2023 Feb;24(2):175-186. doi: 10.1016/S1470-2045(22)00763-X. Epub 2023 Jan 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	50 mg/m2	Intravenous
Subject	Pazopanib	Small molecule	300 mg	Oral

Indications