5177S-11: R1010 Esophageal

CTSU R1010: A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment Of HER2-Overexpressing Esophageal Adenocarcinoma

Type of Study
Cancer (Oncology) - Esophageal
Swedish Cancer Institute
Short Description

Purpose: This randomized phase III trial is studying how well giving radiation therapy, paclitaxel, and carboplatin together with or without trastuzumab works 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 or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.

Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Pathologically confirmed primary adenocarcinoma of the esophagus meeting the following criteria:
    • Involvement of mid (up to 25 cm), distal, or esophagogastric junction
      • Involvement of the stomach up to 5 cm allowed
      • Patients with tumors at the level of the carina or above must undergo bronchoscopy to exclude fistula
    • Stage T1, N1-2 or T2-3, N0-2 disease by chest, abdominal, or pelvic CT scan or whole-body PET/CT scan
      • No T1,N0 or T4 disease
      • No metastatic disease
    • Regional adenopathy including para-esophageal, gastric, gastrohepatic, and celiac (≤ 2 cm) nodes allowed
    • No cervical esophageal or proximal esophageal (15-24 cm) carcinoma
  • HER2-overexpressing adenocarcinoma of the esophagus
  • No evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi
  • Zubrod performance status 0-2
  • No prior systemic chemotherapy for esophageal cancer
  • No prior radiotherapy for esophageal cancer or prior chest radiotherapy
  • No prior anthracycline or taxane
  • No prior therapy with any agent targeting the HER2 pathway or HER1 (EGFR) pathway
  • No prior trastuzumab
  • No concurrent intensity-modulated radiotherapy
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
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