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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
Radiation, paclitaxel, and carboplatin
Followed by surgery 5-8 weeks after completion of radiation

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
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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