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

NCT01016639 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2011-10-17

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

oxaliplatin, capecitabine, radiotherapy

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • Lund University Hospital

    lead OTHER

Principal Investigators

  • Anders Johnsson, MD, PhD · University Hospital Lund

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-07-31
Completion
2009-07-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01016639 on ClinicalTrials.gov