Clinical trial · Interventional
FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer
FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial
NCT01566942CI-TRIAL-00006633unknownPhase 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)
the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX
- description
- In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.
- interventionNames
- Drug: Oxaliplatin
- type
- EXPERIMENTAL
- label
- FOLFIRI
- description
- in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles
- interventionNames
- Drug: Irinotecan
Primary outcomes (1)
- measure
- disease-free survival（DFS）
- timeFrame
- 3-year disease-free survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed adenocarcinoma in colorectal cancer * clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined * no cancer cells were found in ascites * Eastern Cooperative Oncology Group(ECOG) performance status of 0-2 * male or female, between 18 and 75 years old * adequate hematologic, hepatic and renal functions * without severe heart disease in the last 6 months before enrolled. If with hypertension or coronary artery disease, it can be controlled * not enrolled into others clinical trial during this study * all patients should sign the informed consent Exclusion Criteria: * can not be tolerated operation * receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study * can not be tolerated the adverse effect of drugs in these regimens * major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery * metastatic disease more than one organ * pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.