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

Rectal Cancer Dukes B, Dukes C Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00309517
• Other study ID #: ABSCG 92
• Status: Terminated
• Phase: Phase 3
• First received: March 31, 2006
• Last updated: March 31, 2006
• Start date: July 1997

Study information

• Verified date: October 2000
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 700
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Rectal Cancer Dukes B, Dukes C

Intervention

Drug:
• Fluourouracil

• Leucovorin

• MAb 17-1A

Locations

Country	Name	City	State
Austria	Hospital Baden	Baden bei Wien	Lower Austria
Austria	Medical University of Graz, Oncology	Graz	Styria
Austria	Hospital Hainburg	Hainburg	Lower Austria
Austria	General Hospital Linz	Linz	Upper Austria
Austria	Hospital BHB Linz	Linz	Upper Austria
Austria	Hospital Oberpullendorf	Oberpullendorf	Burgenland
Austria	Medical University of Vienna, General Hospital	Vienna
Austria	Hospital Wiener Neustadt, Surgery	Wiener Neustadt	Lower Austria

Sponsors (1)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence-free survival
Primary	Overall survival

External Links

•   Link