UCSF Helen Diller Family Comprehensive Cancer Center
Protocol Summary

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Protocol No.CALGB-80803Principal InvestigatorVenook, Alan
PhaseII (Cancer Control)
Age GroupAdultScopeNational
Secondary Protocol No.80803
TitlePET Scan-Directed Combined Modality Therapy in Esophageal Cancer
ObjectiveTo 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.
Key Eligibility* Surgically resectable, histologically confirmed esophageal adenocarcinoma, including Siewert gastroesophageal (GE) junction adenocarcinomas Types 1 and 2 * 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 * Patients must have detectable fluorine-18-labeled deoxyglucose (FDG) uptake on baseline PET/CT scan of primary tumor * HER 2-positive patients who are eligible for the RTOG-1010 study are not eligible for CALGB-80803
Applicable Disease SitesEsophagus
Therapies InvolvedRadiotherapy
Drugs Involved5-Fu (Fluorouracil)
Adrucil (Fluorouracil)
Carboplatin
Carboplatin Novaplus (Carboplatin)
Eloxatin (Oxaliplatin)
Fluorouracil
Leucovorin
Onxol (Paclitaxel)
Oxaliplatin
Paclitaxel
Paraplatin (Carboplatin)
Taxol (Paclitaxel)
StatusOpen
Participating InstitutionsMt. Zion
San Francisco General Hospital
Eligibility DocumentCALGB-80803_CTGovEligibility_NCT01333033.doc
Other Attachments80803_Lay Summary.pdf