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

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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309517

Enrollment

700

Registered

2006-04-03

Start date

1997-07-31

Completion date

Unknown

Last updated

2006-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer Dukes B, Dukes C

Keywords

Fluorouracil, Leucovorin, MAb 17-1A, Rectal cancer

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).

Interventions

DRUGFluourouracil

DRUGLeucovorin

DRUGMAb 17-1A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Local recurrence-free survival	—
Overall survival	—

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026