UCSF Helen Diller Family Comprehensive Cancer Center
Protocol Summary

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Protocol No.CTSU-NCCTG-N1048Principal InvestigatorVenook, Alan
PhaseII/III (Cancer Control)
Age GroupAdultScopeNational
Secondary Protocol No.N1048
TitleA Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
ObjectivePhase II component: To assure that the selective use of 5FUCMT group (Group 1) maintains the current high rate of pelvic R0 resection and is consistent with non-inferiority for time to local recurrence (TLR). Phase III component: To compare standard 5FUCMT (Group 2) to neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) with respect to the co-primary endpoints of the Time to Local Recurrence (TLR) and Disease Free Survival (DFS).
Key EligibilityAge: 18+ * Diagnosis of rectal adenocarcinoma * For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined-modality, neoadjuvant chemoradiation followed by curative-intent surgical resection * No chemotherapy within 5 years prior to registration
Applicable Disease SitesRectum
Therapies InvolvedChemotherapy multiple agents systemic
Drugs Involved5-Fu (Fluorouracil)
Adrucil (Fluorouracil)
Eloxatin (Oxaliplatin)
Xeloda (Capecitabine)
Participating InstitutionsMt. Zion
Eligibility DocumentCTSU-NCCTG-N1048_CTGovEligibility_NCT01515787.doc
Other AttachmentsN1048_Lay Summary.pdf