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Rectal Cancer Dukes B, Dukes C

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

Sponsored by Austrian Breast & Colorectal Cancer Study Group

About this trial

Last updated 19 years ago

Study ID

ABSCG 92

Status

Terminated

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 28 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

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)

No

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

Locations

Location

Status