Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer

Summary

This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.

Timeline

Start

2011-02-14

Primary completion

2019-12-23

Completion

2023-08-15

Outcome

Missed primary endpoint

registry p = 0.85; Hazard Ratio (HR) 0.97 (95% CI 0.69 to 1.36) NCT01196390 ↗

paper The addition of trastuzumab to neoadjuvant chemoradiotherapy for HER2-overexpressing oesophageal cancer was not effective. PMID 35038433 ↗

Publications

• Safran HP, Winter K, Ilson DH, Wigle D, DiPetrillo T, Haddock MG, Hong TS, Leichman LP, Rajdev L, Resnick M, Kachnic LA, Seaward S, Mamon H, Diaz Pardo DA, Anderson CM, Shen X, Sharma AK, Katz AW, Salo J, Leonard KL, Moughan J, Crane CH. Trastuzumab with trimodality treatment for oesophageal adenocarcinoma with HER2 overexpression (NRG Oncology/RTOG 1010): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):259-269. doi: 10.1016/S1470-2045(21)00718-X. Epub 2022 Jan 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Background	Carboplatin	Small molecule	2 unknown	Intravenous
Background	Paclitaxel	Small molecule	50 mg/m2	Intravenous

Indications