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Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

Conditions

Esophagus

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

To induce a pCR rate of 20% in PET scan non-responders treated with either induction FOLFOX or carboplatin/paclitaxel, who then cross over to the other regimen during radiotherapy.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • Surgically resectable, histologically confirmed esophageal adenocarcinoma, including Siewert GE junction adenocarcinomas Types 1 and 2.
  • T1N1-3M0 or T2-4NanyM0 as determined by EUS and PET/CT (histologic confirmation of lymph involvement is not required). All disease (tumor and nodes) must be both surgically resectable and capable of containment in a radiotherapy field. No T4 tumor with clear evidence of invasion of the vertebral column, heart,
  • great vessels or tracheobronchial tree.
  • All patients must have locoregional staging determined by endoscopic ultrasound (EUS) if technically feasible. Endoscopy reports should clearly state both the T and N stage.
  • 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 FDG-uptake on baseline PET/CT scan of primary tumor. Baseline PET/CT scan should be performed. If it is necessary to repeat baseline PET/CT scan, reimbursement information is available.
  • No prior malignancy within 5 years of registration, with the exception of basal orsquamous 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. However, no prior thoracic RT or abdominal RT or chemotherapy allowed.
  • No known contraindication to the use of 5-FU, taxanes, or platinum compounds.
  • No history of severe hypersensitivity reaction to Cremaphor® EL.
  • Age &ge18 years of age.
  • ECOG Performance Status 0-1.
  • Non-pregnant and non-nursing.

Sponsor:
CALGB
Dates:
10/16/2012
Last Updated:
Study HIC#:
1204010075