CALGB 80803: Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

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CALGB 80803: Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

Primary: 1) To induce a pCR rate of 20% in PET scan responders treated with either induction FOLFOX or carboplatin/paclitaxel, who then cross over to the other regimen during radiotherapy
Secondary: 1) To compare pCR between induction treatment arms among PET/CT responders
2) To compare pCR between induction treatment arms among PET/CT responders
3)If both treatment regimens are found to be efficacious, to directly compare pCR between induction treatment arms among non-responders
4) To determine 8-month PFS in PET/CT scan responders, and in non-responders treated with alternative crossover chemoradiotherapy
5) Estimate the PFS and overall survival, overall and among PET responders and PET/CT non-responders by induction treatment

Protocol Number071203
Principal InvestigatorSalma Jabbour
PhasePhase II
ScopeNational
Applicable Disease SitesEsophagus
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedOXALIPLATIN
CARBOPLATIN
PACLITAXEL
FLUOROURACIL
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.