Study Of Capecitabine And Oxaliplatin In Combination With Radiotherapy In Patients With Unresectable Gastro-Intestinal Cancer

Study Overview

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.

N/A

Stomach Cancer
Gall Bladder Cancer
Bile Ductus Cancer
Pancreas Cancer
Colorectal Cancer

OTHER: oxaliplatin, capecitabine, radiotherapy

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Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-11-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-10-14
First Submitted that Met QC Criteria 2009-11-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-10-17
First Posted (ESTIMATED) 2009-11-19	Results First Posted N/A	Last Verified 2011-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Chemoradiotherapy	OTHER: oxaliplatin, capecitabine, radiotherapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Chemoradiotherapy

OTHER: oxaliplatin, capecitabine, radiotherapy

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Roche Pharma AG
Sanofi-Synthelabo

Investigators

PRINCIPAL_INVESTIGATOR: Anders Johnsson, MD, PhD, University Hospital Lund

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record