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

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ClinicalTrials.gov Identifier: NCT01016639
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : October 17, 2011
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2003
Primary Completion Date : July 2007
Study Completion Date : July 2009


Arms and Interventions

Arm Intervention/treatment
Experimental: Chemoradiotherapy Other: oxaliplatin, capecitabine, radiotherapy


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01016639     History of Changes
Other Study ID Numbers: Version1
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011

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:
Colorectal Neoplasms
Urinary Bladder Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Intestinal Neoplasms
Gallbladder Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites