We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00309517
Recruitment Status : Terminated
First Posted : April 3, 2006
Last Update Posted : April 3, 2006
Information provided by:

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).

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : July 1997
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Local recurrence-free survival
  2. Overall survival

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309517

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
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00309517     History of Changes
Other Study ID Numbers: ABSCG 92
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: April 3, 2006
Last Verified: October 2000

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

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases