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

Colorectal Cancer Clinical Trial

— CORGI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016639
• Other study ID #: Version1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 18, 2009
• Last updated: October 14, 2011
• Start date: June 2003
• Est. completion date: July 2009

Study information

• Verified date: October 2011
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Ductus Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Gall Bladder Cancer
• Gallbladder Neoplasms
• Gastrointestinal Neoplasms
• Pancreas Cancer
• Pancreatic Neoplasms
• Stomach Cancer
• Stomach Neoplasms
• Urinary Bladder Neoplasms

Intervention

Other:
• oxaliplatin, capecitabine, radiotherapy

Locations

Country	Name	City	State
Sweden	Centralsjukhuset, Dept of Oncology	Karlstad
Sweden	University Hospital Lund	Lund
Sweden	University Hospital Malmö, Dept of Oncology	Malmö
Sweden	Karolinska University Hospital	Stockholm
Sweden	Akademiska Sjukhuset	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Lund University Hospital	Roche Pharma AG, Sanofi-Synthelabo

Country where clinical trial is conducted

Sweden,