Clinical trial · Interventional
Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers
NCT00594529CI-TRIAL-00005068unknownPhase 2ClinicalTrials.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 purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.
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 |
|---|---|---|---|
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- interventionNames
- Procedure: Surgery
Primary outcomes (1)
- measure
- Curative resection rates of liver metastases
- timeFrame
- 2 years after the operations
Secondary outcomes (1)
- measure
- Completion rates of neoadjuvant chemotherapy
- timeFrame
- 2 years after the operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers. 2. Liver lesions are measurable by spiral CT or SPIO-MRI scans. 3. Extrahepatic lesions include lung metastases which can be resected curatively. 4. Curative resection for metastatic lesions can be performed with residual hepatic functions preserved. 5. No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA 6. No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection 7. Performance status (ECOG): 0-1 8. Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved. Exclusion Criteria: Excluded are cases with conditions as below: 1. Peritoneal or pleural fluid retention to be drained. 2. Multiple malignancies to be treated. 3. Peripheral neural disturbances. 4. Active infectious diseases. 5. Severe watery diarrhea. 6. Mental disturbances. 7. Treatment history of continuous, oral or intravenous steroid therapy. 8. Previous history of ischemic heart diseases. 9. Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure. 10. Pregnant. 11. Previous history of severe drug-induced allergy.
References
Publications (1)
- DERIVEDNagayama S, Hasegawa S, Hida K, Kawada K, Hatano E, Nakamura K, Seo S, Taura K, Yasuchika K, Matsuo T, Zaima M, Kanazawa A, Terajima H, Tada M, Adachi Y, Nishitai R, Manaka D, Yoshimura T, Doi K, Horimatsu T, Mitsuyoshi A, Yoshimura K, Niimi M, Matsumoto S, Sakai Y, Uemoto S. Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers. Int J Clin Oncol. 2017 Apr;22(2):316-323. doi: 10.1007/s10147-016-1050-5. Epub 2016 Oct 17. PMID 27752787