Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer
NCT ID: NCT01016639
Last Updated: 2011-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
106 participants
INTERVENTIONAL
2003-06-30
2009-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemoradiotherapy
oxaliplatin, capecitabine, radiotherapy
Interventions
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oxaliplatin, capecitabine, radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Sanofi-Synthelabo
INDUSTRY
Lund University Hospital
OTHER
Responsible Party
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Principal Investigators
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Anders Johnsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Lund
Locations
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Centralsjukhuset, Dept of Oncology
Karlstad, , Sweden
University Hospital Lund
Lund, , Sweden
University Hospital Malmö, Dept of Oncology
Malmo, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Countries
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Other Identifiers
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Version1
Identifier Type: -
Identifier Source: org_study_id