NCT01016639

Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer

Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors. The trial consists ot two separate studies; CORGI-U in patients with stomach- bile ducts- gallbladder and pancreas cancer, and CORGI-L in patients with colorectal cancer. CORGI-U will be designed as a phase-I-II-study,in which the first part will be a chemotherapy dose finding study, followed by a phase II part to establish response rates. All subjects receives radiotherapy concommitant. CORGI-L is a phase II trial, in which patients are treated with chemotherapy at fixed doses with radiotherapy concommitant.

Conditions

• Stomach Cancer
• Gall Bladder Cancer
• Bile Ductus Cancer
• Pancreas Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	oxaliplatin, capecitabine, radiotherapy

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-07-01
• Completion: 2009-07-01
• First posted: 2009-11-19
• Last updated: 2011-10-17

Locations

5 sites across 1 country: Sweden