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

Tracking Information

First Received Date ^ICMJE

March 31, 2006

Last Updated Date

March 31, 2006

Start Date ^ICMJE

July 1997

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Local recurrence-free survival
Overall survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Rectal Cancer Dukes B, Dukes C

Intervention ^ICMJE

Drug: Fluourouracil
Drug: Leucovorin
Drug: MAb 17-1A

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

700

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00309517

Other Study ID Numbers ^ICMJE

ABSCG 92

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Austrian Breast & Colorectal Cancer Study Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Raimund Jakesz, MD

Austrian Breast & Colorectal Cancer Study Group

Information Provided By

Austrian Breast & Colorectal Cancer Study Group

Verification Date

October 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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