Official Title: “Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

• Other: oxaliplatin, capecitabine, radiotherapy

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Chemoradiotherapy

Inclusion Criteria:

• Over 18 years of age
• Measurable disease according to RECIST
• ECOG Performance Status 0-1
• ANC over 1.5 x 10 9/L
• Platelets over 100 x 10 9/L
• Creatinine less than 1.5 x ULN
• Bilirubin less than 1.5 x ULN
• ALT less than 2.5 x ULN
• Signed informed concent

Exclusion Criteria:

• Prior radiotherapy to the same local
• Prior chemotherapy for locally advanced or metastatic disease
• Pregnancy or breast feeding
• Peripheral neuropathy more than grade 1
• Uncontrolled diarrhéa
• Other serious uncontrolled concomitant illness
• Lymph node metastasis that can not be included in the GTV (gross tumor volume), without exceeding the stipulated radiotherapy doses in organs at risk

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Lund University Hospital

Overall Clinical Trial Officials and Contacts

Anders Johnsson, MD, PhD Principal Investigator University Hospital Lund, Dept of Oncology  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01016639

Study ID Number: Version1

ClinicalTrials.gov Identifier: NCT01016639

Health Authority: Sweden: Medical Products Agency