PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy

Status: Recruiting
Phase: Phase 2
Diagnosis: Gastrointestinal Malignancies, Esophageal Cancer
NCT ID: NCT01333033 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-189

 

RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.

 

Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Theodore Hong, MD, Massachusetts General Hospital

Site-responsible Investigators:
Harvey Mamon, MD, PhD, Brigham and Women's Hospital
Mark Huberman, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

DISEASE CHARACTERISTICS: - Surgically resectable, histologically confirmed esophageal adenocarcinoma, including Siewert gastroesophageal (GE) junction adenocarcinomas Types 1 and 2 - T1 N1-3 M0 or T2-4 N any M0 as determined by endoscopic ultrasound (EUS) and PET/CT (histologic confirmation of lymph involvement is not required) - All patients must have locoregional staging determined by EUS if technically feasible - All disease (tumor and nodes) must be both surgically resectable and capable of containment in a radiotherapy field - Endoscopy reports should clearly state both the T and N stage - No T4 tumor with clear evidence of invasion of the vertebral column, heart, great vessels, or tracheobronchial tree - No evidence of distant metastases (as determined by EUS or PET/CT) - Patients with cervical, supraclavicular, or other nodal disease that is either not included in the radiation field or is not able to be resected at the time of esophagectomy are not eligible - Patient must have pre-resection tissue available for central pathology review - Patients must have detectable fluorine-18-labeled deoxyglucose (FDG) uptake on baseline PET/CT scan of primary tumor PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - ANC ≥ 1,500/μL - Platelet count ≥ 100,000/μL - Hemoglobin ≥ 9 g/dL - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - Creatinine clearance ≥ 60 mL/min - AST/ALT ≤ 2.5 times ULN - Not pregnant or nursing - Negative pregnancy test - No prior malignancy within 5 years, with the exception of basal or squamous cell skin cancers, or in situ bladder or cervical cancer - Patients with prior malignancy treated with surgery only and disease-free for more than 5 years are eligible - No history of severe hypersensitivity reaction to Cremaphor® EL - No known contraindication to the use of fluorouracil, taxanes, or platinum compounds PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior thoracic radiotherapy (RT), abdominal RT, or chemotherapy - No concurrent epoetin
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