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Active Clinical Trials

CASE 6213

Active
Allegheny General Hospital
Allegheny General Hospital

Allegheny Valley Hospital
Allegheny Valley Hospital

Jefferson Hospital
Jefferson Hospital

West Penn Hospital
West Penn Hospital

Wexford Health + Wellness Pavilion
Wexford Health + Wellness Pavilion

Sponsor: 
Cleveland Clinic
Contact: 

For more information, please contact Kelli Davis at 412-578-4639 or Kelli.Davis@ahn.org

A Phase II Trial of modified FOLFOX-6 Induction ChemotherapyFollowed by Esophagectomy and Post-operative Response Based Concurrent Chemoradiotherapy in Patients with Locoregionally Advanced Adenocarcinoma of the Esophagus, Gastro-esophageal Juion, and Gastric Cardia.

Purpose: 

Primary Objectives:

  • To assess the ability of response adapted adjuvant chemoradiotherapy to improvethe 1 year RFS compared to historical data in patients with > 50% remaining viable tumor after induction chemotherapy.
  • Secondary Objectives:
  • To determine the rates of symptomatic, endoscopic, and pathologic response to induction chemotherapy.
  • To determine the rate of R0 resection after induction chemotherapy.
  • To establish the toxicity profile of this tri-modality regimen.
  • To assess the recurrence free survival (RFS) and overall survival (OS) of this trimodalitytherapy regimen for the entire cohort and in patients who do and do not achieve a pathologic response.
  • To assess patterns of failure and assess the rates of distant metastatic control (DMC) and locoregional control (LRC) of this tri-modality therapy regimen.

Eligible for Study:Screening studies and evaluations will be used to determine the eligibility of each subject for study inclusion. All evaluations must be completed 42 days (6 weeks) prior to administration of protocol therapy.

  • Informed consent
  • History and physical exam
  • Performance status (ECOG)
  • EGD / EUS
  • PET / CT (with diagnostic CT abdomen / pelvis preferred)
  • PFT (Spirometry with DLCO)
  • Cardiac stress test (dobutamine stress echocardiogram preferred)
  • CBC
  • BMP and HFP (a CMP may substitute for BMP and HFP)
  • Serum-HCG in women of childbearing potential
  • Correlative study- Ki67 IHC and HER2 FISH / IHC will be performed on initial biopsy specimens after enrollment.