Clinical trial · Interventional
Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Adjuvant Chemoimmunotherapy for Colorectal Cancer
NCT00003063CI-TRIAL-00012259unknownPhase 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)
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| levamisole hydrochloride | Drug | — | UNRESOLVED |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage T3-T4 N0 or T1-T4 N1-3 colorectal cancer * No evidence of residual disease after surgery * Tumor located above peritoneal reflection * No distant metastases PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGPT less than 2 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No serious cardiac ischemia Other: * Adequate metabolic functions * No prior neoplasm * No prior/concurrent illness * No insulin-dependent diabetes PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for the current cancer Chemotherapy * No prior chemotherapy for the current cancer Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for the current cancer Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.