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

October 14, 2011 updated by: Lund University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Sweden
      • Karlstad, Sweden
        • Centralsjukhuset, Dept of Oncology
      • Lund, Sweden
        • University Hospital Lund
      • Malmö, Sweden
        • University Hospital Malmö, Dept of Oncology
      • Stockholm, Sweden
        • Karolinska University Hospital
      • Uppsala, Sweden
        • Akademiska sjukhuset

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemoradiotherapy
Other: oxaliplatin, capecitabine, radiotherapy

Collaborators and Investigators

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

Sponsor

Lund University Hospital

Collaborators

Roche Pharma AG
Sanofi-Synthelabo

Investigators

  • Principal Investigator: Anders Johnsson, MD, PhD, University Hospital Lund

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 Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (Estimate)

November 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 17, 2011

Last Update Submitted That Met QC Criteria

October 14, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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