Clinical trial · Interventional
Combined Resection of Colorectal Metastases
Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II 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)
This is a Phase II study of combined surgical resection for patients with both intra- and extra-hepatic metastases from colorectal cancer. The primary objective is to determine the two-year disease free survival (DFS) of patients who undergo surgical resection of both intra- and extra-hepatic metastases from colorectal cancer. The secondary objectives are to determine the overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of life, and hospital length of stay.
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 |
|---|---|---|---|
| surgical resection for patients with both intra- and extra-hepatic metastases | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- two-year disease free survival (DFS)
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of life, hospital length of stay
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with both intra-hepatic and extra-hepatic metastases from colorectal cancer * Number of extra-hepatic metastases must be 3 or less on pre-operative imaging * All metastatic deposits must be resectable with clear margins * No contra-indications to major surgery * ECOG performance of 0, 1 or 2 * Age 18 or older * Pregnant women or women of childbearing potential are eligible if they agree to use 2 methods of effective contraception during treatment protocol * Written informed consent can be obtained Exclusion Criteria: * Colorectal primary in situ * Four or more extra-hepatic lesions on pre-operative imaging * Significant medical or psychiatric conditions that preclude major surgery or may interfere with patient compliance * Patients receiving investigational drugs with unknown surgical risks * Failure to meet inclusion criteria
References
Publications (0)
Data not yet available