Back to resultsRandomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C
Primary Purpose
Rectal Cancer Dukes B, Dukes C
Status
Terminated
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Fluourouracil
Leucovorin
MAb 17-1A
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer Dukes B, Dukes C focused on measuring Fluorouracil, Leucovorin, MAb 17-1A, Rectal cancer
Eligibility Criteria
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
Sites / Locations
- Hospital Oberpullendorf
- Hospital Baden
- Hospital Hainburg
- Hospital Wiener Neustadt, Surgery
- Medical University of Graz, Oncology
- General Hospital Linz
- Hospital BHB Linz
- Medical University of Vienna, General Hospital
Outcomes
Primary Outcome Measures
Local recurrence-free survival
Overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00309517
First Posted
March 31, 2006
Last Updated
March 31, 2006
Sponsor
Austrian Breast & Colorectal Cancer Study Group
1. Study Identification
Unique Protocol Identification Number
NCT00309517
Brief Title
Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2000
Overall Recruitment Status
Terminated
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Austrian Breast & Colorectal Cancer Study Group
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer Dukes B, Dukes C
Keywords
Fluorouracil, Leucovorin, MAb 17-1A, Rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluourouracil
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Type
Drug
Intervention Name(s)
MAb 17-1A
Primary Outcome Measure Information:
Title
Local recurrence-free survival
Title
Overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raimund Jakesz, MD
Organizational Affiliation
Austrian Breast & Colorectal Cancer Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Oberpullendorf
City
Oberpullendorf
State/Province
Burgenland
ZIP/Postal Code
7350
Country
Austria
Facility Name
Hospital Baden
City
Baden bei Wien
State/Province
Lower Austria
ZIP/Postal Code
2500
Country
Austria
Facility Name
Hospital Hainburg
City
Hainburg
State/Province
Lower Austria
ZIP/Postal Code
2410
Country
Austria
Facility Name
Hospital Wiener Neustadt, Surgery
City
Wiener Neustadt
State/Province
Lower Austria
ZIP/Postal Code
2700
Country
Austria
Facility Name
Medical University of Graz, Oncology
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Facility Name
General Hospital Linz
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Facility Name
Hospital BHB Linz
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medical University of Vienna, General Hospital
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Links:
URL
http://www.abcsg.at
Description
Related Info
Learn more about this trial
Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C
We'll reach out to this number within 24 hrs