A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic
- Conditions
- ocally Advanced, Unresectable Pancreatic Cancer
- Registration Number
- JPRN-UMIN000028626
- Lead Sponsor
- niversity of Texas Southwestern Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 103
Not provided
1.Subjects receiving other investigational agents. 2.History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in study. 3.Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 4.Prior treatment for pancreatic cancer preceding registration 5.Prior radiation to the upper abdomen 6.Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy). 7.Body weight >100 kg 8.Active inflammatory bowel disease or active gastric/duodenal ulcer 9.Metal implants in the upper abdomen 10.Expected medical intolerance of radiotherapy, concurrent chemotherapy, and/or adjuvant chemotherapy. 11.History of HIV or hepatitis B or C
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method