Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C
NCT ID: NCT00309517
Last Updated: 2006-04-03
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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TERMINATED
PHASE3
700 participants
INTERVENTIONAL
1997-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Fluourouracil
Leucovorin
MAb 17-1A
Eligibility Criteria
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Inclusion Criteria
* Age: 18-80 years
* Karnofsky Performance Status \> 80
* Adequate bone marrow reserve (leukocytes \> 4,000, thrombocytes \> 105/mm3, Hb \> 10g %), renal and hepatic functions (total bilirubin and creatinine \< 1.25 x ULN)
Exclusion Criteria
* R1, R2; carcinosis peritonei
* Start of treatment \> 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
* Previous application of a murine or chimeric monoclonal antibody or antibody fragment
* Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months pre-study
* Known hypersensitivity to animal protein
* Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell. gravis, cerebral seizure disorder, et al.
* Pregnancy or lactation
18 Years
80 Years
ALL
No
Sponsors
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Austrian Breast & Colorectal Cancer Study Group
NETWORK
Principal Investigators
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Raimund Jakesz, MD
Role: PRINCIPAL_INVESTIGATOR
Austrian Breast & Colorectal Cancer Study Group
Locations
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Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria
Hospital Baden
Baden, Lower Austria, Austria
Hospital Hainburg
Hainburg an der Donau, Lower Austria, Austria
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, Austria
Medical University of Graz, Oncology
Graz, Styria, Austria
General Hospital Linz
Linz, Upper Austria, Austria
Hospital BHB Linz
Linz, Upper Austria, Austria
Medical University of Vienna, General Hospital
Vienna, Vienna, Austria
Countries
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Related Links
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Related Info
Other Identifiers
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ABSCG 92
Identifier Type: -
Identifier Source: org_study_id