Phase 2 N=71 Treatment

Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Pancreatic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00456599 ↗

Enrolled (actual)

Serious AEs

39.4%

Results posted

Apr 2014

Primary outcome: Primary: Two-year Disease Free Survival. — 26.1 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: gemcitabine (Drug); oxaliplatin (Drug); Radiation (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan Rogel Cancer Center
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Two-year Disease Free Survival.	26.1	—
SECONDARY Time to Treatment Failure	10.4	—
SECONDARY Overall Survival	18.2	—

Summary

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of 1500/mm3, platelets > 100,000/mm3, serum Cr grade 2 are ineligible.
Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00456599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.