Clinical trialPhase 2Completed
Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- April 2007
- Expected end
- January 2013
- Enrollment
- 71 participants
- Sites
- 4
- Primary outcomes
- Two-year Disease Free Survival.
- Sponsor
- Other
- Results posted
- 2014-04-15
- Last update
- 3 December 2015
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Brief summary public domain (ClinicalTrials.gov)
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Two-year Disease Free Survival. [two years]. Number, percentage of patients (95% Confidence Interval). Oxaliplatin & Gemcitabine With Radiation (n=41): 26.1 (16.1 to 37.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Treatment Failure [2 years]. Median, months (Full Range). Oxaliplatin & Gemcitabine With Radiation (n=41): 10.4 (2.3 to 35.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [5 years]. Median, months (95% Confidence Interval). Oxaliplatin & Gemcitabine With Radiation (n=68): 18.2 (13 to 26.9).
Papers 1
- Registry-listed results paperA multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with … DOI 10.1002/cncr.28117↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.