Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C
A Prospectively Randomized Study on Neoadjuvant Radio-Chemotherapy in Patients With Operated Rectal Carcinoma Dukes B and C (pT2, pN1-3; pT3-4, pN0-3; M0.
1 other identifier
interventional
700
1 country
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1997
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedApril 3, 2006
October 1, 2000
March 31, 2006
March 31, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Local recurrence-free survival
Overall survival
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hospital Oberpullendorf
Oberpullendorf, Burgenland, 7350, Austria
Hospital Baden
Baden, Lower Austria, 2500, Austria
Hospital Hainburg
Hainburg an der Donau, Lower Austria, 2410, Austria
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, 2700, Austria
Medical University of Graz, Oncology
Graz, Styria, 8036, Austria
General Hospital Linz
Linz, Upper Austria, 4020, Austria
Hospital BHB Linz
Linz, Upper Austria, 4020, Austria
Medical University of Vienna, General Hospital
Vienna, Vienna, 1090, Austria
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raimund Jakesz, MD
Austrian Breast & Colorectal Cancer Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
July 1, 1997
Last Updated
April 3, 2006
Record last verified: 2000-10