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

This study has been terminated.
Sponsor:
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00309517
First received: March 31, 2006
Last updated: NA
Last verified: October 2000
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Rectal Cancer Dukes B, Dukes C
Drug: Fluourouracil
Drug: Leucovorin
Drug: MAb 17-1A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • Local recurrence-free survival
  • Overall survival

Estimated Enrollment: 700
Study Start Date: July 1997
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309517

Locations
Austria
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
Hospital Baden
Baden bei Wien, Lower Austria, Austria, 2500
Hospital Hainburg
Hainburg, Lower Austria, Austria, 2410
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, Austria, 2700
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
General Hospital Linz
Linz, Upper Austria, Austria, 4020
Hospital BHB Linz
Linz, Upper Austria, Austria, 4020
Medical University of Vienna, General Hospital
Vienna, Austria, 1090
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Investigators
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00309517     History of Changes
Other Study ID Numbers: ABSCG 92
Study First Received: March 31, 2006
Last Updated: March 31, 2006
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
Fluorouracil
Leucovorin
MAb 17-1A
Rectal cancer

ClinicalTrials.gov processed this record on October 02, 2014