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.

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Key information

Conditions

Stomach Cancer Bile Ductus Cancer Biliary Tract Diseases Biliary Tract Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gall Bladder Cancer Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centralsjukhuset, Dept of Oncology, Karlstad, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxaliplatin, capecitabine, radiotherapy

Other

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Collaborators

Roche Pharma AG
Sanofi-Synthelabo

Registry information

Official study title

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

Acronym: CORGI

Important dates

Study start: 2003
Primary completion: 2007
Study completion: 2009
First posted: Nov 19, 2009
Registry last updated: Oct 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed