Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer (CORGI)
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|ClinicalTrials.gov Identifier: NCT01016639|
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : October 17, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Stomach Cancer Gall Bladder Cancer Bile Ductus Cancer Pancreas Cancer Colorectal Cancer||Other: oxaliplatin, capecitabine, radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2009|
|Experimental: Chemoradiotherapy||Other: oxaliplatin, capecitabine, radiotherapy|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|