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

Status: Recruiting
Phase: Phase 3
Diagnosis: Radiation Oncology
NCT ID: NCT01196390 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-163


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


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Harvey Mamon, MD, PhD, Brigham and Women's Hospital

Site-responsible Investigators:
Theodore Hong, MD, Massachusetts General Hospital

Brigham and Women's Hospital: Kristin Roper, 617-525-7387, kroper@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - 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 - Must have undergone endoscopy with biopsy - HER2-overexpressing adenocarcinoma of the esophagus - Primary tumor tissue samples must be submitted and centrally assessed within the past 56 days - Disease must be encompassed in 1 radiotherapy field - Able to undergo curative resection within 56 days after completion of chemoradiation - No evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi - Zubrod performance status 0-2 - ANC ≥ 1,500 cells/mm³ - Platelet count ≥100,000 cells/mm³ - Hemoglobin (Hb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hb ≥ 8.0 g/dL allowed) - Creatinine ≤ 2 times upper limit of normal (ULN) - Bilirubin ≤ 1.5 times ULN - AST ≤ 3.0 times ULN - LVEF normal - Negative pregnancy test - Not pregnant or nursing - Fertile patients must use effective contraception during and for ≥ 60 days after completion of chemotherapy or trastuzumab - No prior invasive malignancy except non-melanomatous skin cancer or curatively treated carcinoma in situ of the breast, oral cavity, or cervix with no evidence of disease within the past 2 years - No medical contraindications to esophagectomy - No prior allergic reaction to the study drugs involved in this protocol or to a monoclonal antibody - No history of congestive heart failure - No severe or active comorbidity defined as any of the following: - Unstable angina within the past 6 months - Transmural myocardial infarction within the past 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics - AIDS or immunocompromised patients - HIV testing is not required - No prior systemic chemotherapy for esophageal cancer - Prior chemotherapy for a different cancer allowed - 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 - No other concurrent radiotherapy - No other concurrent investigational agents - No other concurrent cytotoxic agents
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