Clinical trial · Interventional
Treatment Outcomes of Hepatic Metastasis After FOLFOX-4 Therapy
Oncologic Outcomes of Surgical Versus Non-surgical Methods for the Treatment of Resectable Colorectal Liver-confined Metastases Converted From Initially Non-resectable Metastases by FOLFOX-4 Neoadjuvant Chemotherapy: A Randomized Clinical Trial
- 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 role of surgical resection in the subset of patients with resectable hepatic metastases converted from initially non-resectable liver metastasis was still not clearly established. To further explore the oncologic results of surgical versus non-surgical methods for the treatment of this subset of patients, we designed and conducted the present randomized prospective study beginning in 2002. The present study was based on the following arguments against the predominant survival benefits of surgical resection in previous reported series: (1) The initially non-resectable liver metastasis was basically a disseminated disease, even though some metastases were highly responsive to chemotherapy and become resectable; (2) Since the evaluation of resectability was based on the imaging studies, it was difficult to consider the surgical resection as "curative" for the resectable hepatic metastases converted from non-resectable ones, given the limitation of the current imaging stools of high-technology; (3) The resectable hepatic metastases after neoadjuvant chemotherapy might represent a subset of hepatic metastases biologically highly responsive to chemotherapy and the time-to-progression for these metastases might be fairly long after a response. Additionally, these metastases might be also biologically responsive to other cytotoxic or targeted therapies that justified the patients' continuous adoption of non-surgical treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hepatic resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- The patients with secondary resectable colorectal hepatic metastasis undergoing surgery
- interventionNames
- Procedure: Hepatic resection
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- The patients with secondary resectable colorectal hepatic metastasis who underwent continuous chemotherapy
- interventionNames
- Procedure: Hepatic resection
Primary outcomes (1)
- measure
- Both groups of patients were analyzed with intention-to-treat principle. The primary end-point was time-to-progression. The secondary points were overall survival and surgical morbidity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Secondary resectable hepatic metastasis converted by FOLFOX-4 regimen. 2. age between 18-80 y/o. 3. no extra-hepatic disease 4. life expectancy ≥ 3 months 5. Karnofsky performance status ≥ 50%. 6. WBC count ≥ 4,000/μl, platelet count ≥ 100,000/μl, serum bilirubin ≤ 2.0 mg/dl and normal serum glucose and electrolyte levels.- Exclusion Criteria: 1. Secondary resectable hepatic metastasis with extra-hepatic disease 2. poor liver function including: serum bilirubin \> 2.0 mg/dl, GOT,GPT \>100 U/L 3. severe steatosis hepatitis or sinusoidal dilation 4. Karnoofsky performance status \<50%.-
References
Publications (0)
Data not yet available