Berkshire Health Systems - The region's leading provider of comprehensive health care services
Berkshire Medical Center Northern Berkshire Campus of BMC Fairview Hospital Berkshire VNA & Hospice Long Term Care
About Berkshire Health Systems BHS Locations Our Services Employment Opportunities Medical Education Physician Finder
Related Links

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


font size Decrease (-) Default Increase (+)
Print
Email