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

This study has been completed.
Sponsor:
Collaborators:
Roche Pharma AG
Sanofi-Synthelabo
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT01016639
First received: November 18, 2009
Last updated: October 14, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Stomach Cancer
Gall Bladder Cancer
Bile Ductus Cancer
Pancreas Cancer
Colorectal Cancer
 Other: oxaliplatin, capecitabine, radiotherapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University Hospital:

Enrollment: 106
Study Start Date: June 2003
Study Completion Date: July 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemoradiotherapy Other: oxaliplatin, capecitabine, radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016639

Locations
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, Sweden
Sponsors and Collaborators
Lund University Hospital
Roche Pharma AG
Sanofi-Synthelabo
Investigators
Principal Investigator: Anders Johnsson, MD, PhD University Hospital Lund
  More Information

No publications provided

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01016639     History of Changes
Other Study ID Numbers: Version1
Study First Received: November 18, 2009
Last Updated: October 14, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University Hospital:
Stomach cancer
Gall bladder cancer
Bile ductus cancer
Pancreas cancer
Colorectal cancer
 Chemo radiotherapy
Phase I-II
Oxaliplatin
Capecitabine
Response

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Colorectal Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Gallbladder Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Digestive System Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Oxaliplatin
Capecitabine
Fluorouracil
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013