Status:
TERMINATED
Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Conditions:
Rectal Cancer Dukes B, Dukes C
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A c...
Eligibility Criteria
Inclusion
- Patients with histologically verified operable rectal cancer Dukes B and C (Stage II, T2-4, N0-3, M0), R0
- 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
- Colon cancer
- 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
Key Trial Info
Start Date :
July 1 1997
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00309517
Start Date
July 1 1997
Last Update
April 3 2006
Active Locations (8)
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1
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
2
Hospital Baden
Baden, Lower Austria, Austria, 2500
3
Hospital Hainburg
Hainburg an der Donau, Lower Austria, Austria, 2410
4
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, Austria, 2700