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Clinical Trials/NCT01016639
NCT01016639
Completed
Phase 1

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

Lund University Hospital5 sites in 1 country106 target enrollmentJune 2003
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ConditionsStomach CancerGall Bladder CancerBile Ductus CancerPancreas CancerColorectal Cancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Stomach Cancer
Sponsor
Lund University Hospital
Enrollment
106
Locations
5
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2003
End Date
July 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Not specified

Study Sites (5)

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