Clinical trial · Interventional
Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)
A Single Arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of Capecitabine Plus Oxaliplatin (XELOX) in the Peri-operative Treatment of Patients With Potentially Resectable Liver Metastasis From Colorectal Cancer
NCT00997685CI-TRIAL-00002718unknownPhase 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)
This is a single arm, open-label phase II study to evaluate the efficacy and safety of Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with potentially 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 |
| Potentially Resectable Liver Metastasis From CRC | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine plus oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine plus oxaliplatin，mCRC
- interventionNames
- Drug: Capecitabine plus oxaliplatin
Primary outcomes (1)
- measure
- To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
- timeFrame
- 3.6 years
Secondary outcomes (3)
- measure
- To investigate the response rate
- timeFrame
- 3.6 years
- measure
- To evaluate the R0 resection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age of 18 and 65 * Histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis * Potentially curable by resection, as determined by a surgeon with hepatic surgery expertise * No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis * Patients with adequate hepative, renal and bone marrow function * Signed written informed consent Exclusion Criteria: * Pregnant or nursing patients (fertile patients must use effective contraception) * Other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix * Preexisting grade 2 or greater peripheral neuropathy * Concurrent uncontrolled illness * Ongoing or active infection * Psychiatric illness or social situation that would preclude study compliance * Less than 6 months since prior adjuvant fluorouracil-based chemotherapy * Prior chemotherapy for liver metastasis * Prior oxaliplatin for colorectal cancer * Prior or concurrent hepatic artery infusion chemotherapy for metastatic disease * Prior or concurrent radiotherapy for metastatic disease * Prior or concurrent radiofrequency ablation for metastatic disease * concurrent treatment with any other anti-cancer therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.