Clinical trial · Interventional
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.
NCT00309517CI-TRIAL-00000316terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer Dukes B, Dukes C | Rectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluourouracil | Drug | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| MAb 17-1A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Local recurrence-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.