Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer (CORGI)
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.
|Stomach Cancer Gall Bladder Cancer Bile Ductus Cancer Pancreas Cancer Colorectal Cancer||Other: oxaliplatin, capecitabine, radiotherapy||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016639
|Centralsjukhuset, Dept of Oncology|
|University Hospital Lund|
|University Hospital Malmö, Dept of Oncology|
|Karolinska University Hospital|
|Principal Investigator:||Anders Johnsson, MD, PhD||University Hospital Lund|