| Principal Name | Harvey Zimbler, MD |
|---|---|
| Contact Name | Gloria Gero |
| Phone | (413) 496-8205 |
| Alternate Phone | (413) 443-6000 |
| Fax | (413) 443-2203 |
| Title | RTOG 1010 - " A Phase III Trial Evaluating the Addition of Trastuzumab To Trimodallity Treatment of HER2-Overespressing Esophageal Adenocarcinoma |
| Description | ARM 1 Radiation , paclitaxel, carboplatin, and trastuzumab followed by surgery 5-8 weeks after completion of radiation Then maintenance trastuzumab, every 3 weeks for 13 treatments ARM 2 Radiation, paclitaxel, and carboplatin Followed by surgery 5-8 weeks after completion of radiation Objectives: To determine if trastuzumab increases disease-free survival when combined with trimodality treatment (radiaiton plus chemotherapy followed by surgery) for patients with HER2-overexpressing esophageal adenocarcinoma Secondary Objective: to evaluate if the addition of trastuzumab to trimodality treatment increases the pathologic complete response rate and overall survival for patients with HER2-overexpressing esophageal adenocarinoma |
| Treatment | Oncology |
| Inclusion/Notes | Eligibility: -pathologically confirmed primary adenocarcinoma of the esophagus that involves the mid (up to 25 cm), distal, or esophagogastric junction. The cancer may involve the stomach up to 5 cm. -Endoscopy with biopsy -Stage T1N1-2, T2-3N0-2, according to AJCC 7th edition stagaing -Age over 18 years old -Zubrod performance status 0-2 -PRIOR TO STEP 2 REGISTRATION(HER2-postive patients only) -Surgical consultation to confirm that patient will be able to undergo curative resection after completion of chemoradiation within 56 days prior to Step 2 registration -Radiation oncology consultation to confirm that disease can be encompassed in a radiotherapy field within 56 days prior to Step 2 registration -Consultation with a medical oncologist within 56 days prior to Step 2 registration -LVEF per institutional limit of normal by cardiac echo or MUGA scan within 56 days prior to Step 2 Ineligibility: Patients with cervical esophageal carcinoma Patients with T1N0 disease, T4 disease and proximal esophageal cancers (15-24 cm) Prior radiation for esophageal cancer or prior chest radiotherapy Medical contraindications to esophagectomy Prior therapy with trastuzumab Previous history of congestive heart failure |
| Status | accruing |
| Current Trial Type | treatment |
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