Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C

Phase 3

Terminated

• Conditions: Rectal Cancer Dukes B, Dukes C

• Registration Number: NCT00309517
• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group

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 chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).

Detailed Description

Not available

Study Timeline

• Study Start: 1997-07
• Status Verified: 2000-10
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Last Update Submitted: 2006-03-31
• Study First Posted: 2006-04-03
• Last Update Posted: 2006-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local recurrence-free survival
Overall survival

Trial Locations

Locations (8)

Hospital Baden; 🇦🇹 Baden bei Wien, Lower Austria, Austria

Hospital Hainburg; 🇦🇹 Hainburg, Lower Austria, Austria

Hospital Oberpullendorf; 🇦🇹 Oberpullendorf, Burgenland, 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, Austria