Phase 2 Study of Chemoradiotherapy Alone or With Surgery for Esophageal and Gastric Cancer

Title: A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases¹

Principal Investigator: Quynh nhu Nguyen, MD, MD Anderson Cancer Center

Description: For this open-label phase 2 study (ClinicalTrials.gov Identifier: NCT03161522), researchers are evaluating the safety and efficacy of additional chemotherapy and radiation, alone or with surgery, among patients with esophageal or gastric cancer with oligometastases whose disease has not progressed after at least 6 cycles of chemotherapy.

Patients will be randomly assigned to receive maintenance chemotherapy (cisplatin, 5-FU, mitomycin C, vindesine, or paclitaxel, as monotherapy or in combination) or local consolidation therapy, which includes the aforementioned chemotherapy plus external beam radiation therapy and surgery if eligible.

The primary outcome is overall survival. The estimated study enrollment is 100 patients.

For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03161522.

Status: Open and recruiting patients as of February 23, 2018.

This study is sponsored by MD Anderson Cancer Center.

Reference

1. ClinicalTrials.gov. Chemoradiation +/- surgery versus systemic therapy for esophageal or gastric cancer with oligometastases. NCT03161522. https://clinicaltrials.gov/ct2/show/NCT03161522. Accessed February 23, 2018.