Clinical trial · Interventional
Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)
Phase III Study to Compared Preoperative and Postoperative With FOFLOX4 Chemotherapy and Postoperative With FOFLOX4 Chemotherapy in Patients With Resectable Liver Metastasis From Colorectal Cancer
NCT01035385CI-TRIAL-00002910unknownPhase 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 study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.
Conditions
Conditions (2)
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 |
| Liver Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOFLOX4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOFLOX4,resectable liver metastasis from CRC
- interventionNames
- Drug: FOFLOX4
Primary outcomes (1)
- measure
- progression free survival (PFS)
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about: * Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope. * Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients. 2. Age of≥18 and ≤80 3. ECOG≤2 4. Signed written informed consent Exclusion Criteria: 1. Peripheral neuropathy(CTC\>1) 2. Had a neurological or mental disorders 3. Active infection 4. Allergy to Platinum-based and other drugs 5. Other acute diseases including infection, heart-disease(CHF, stable or unstable angina) 6. Pregnant or nursing patients
References
Publications (0)
Data not yet available
No reference posted for this study.