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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

November 18, 2009
October 14, 2011
June 2003
July 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01016639 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stomach Cancer
  • Gall Bladder Cancer
  • Bile Ductus Cancer
  • Pancreas Cancer
  • Colorectal Cancer
Other: oxaliplatin, capecitabine, radiotherapy
Experimental: Chemoradiotherapy
Intervention: Other: oxaliplatin, capecitabine, radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
July 2009
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01016639
Version1
No
Lund University Hospital
Lund University Hospital
  • Roche Pharma AG
  • Sanofi-Synthelabo
Principal Investigator: Anders Johnsson, MD, PhD University Hospital Lund
Lund University Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP