Clinical trial · Interventional
Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis
A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis
NCT00630045CI-TRIAL-00001333unknownPhase 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 aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .
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 |
| Resectable Liver Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant chemotherapy with oxaliplatin and capecitabine | Drug | — | UNRESOLVED |
| resection of liver metastasis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 2\~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis
- interventionNames
- Drug: neoadjuvant chemotherapy with oxaliplatin and capecitabine
- Procedure: resection of liver metastasis
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- no neoadjuvant chemotherapy, resect the liver metastasis directly
- interventionNames
- Procedure: resection of liver metastasis
Primary outcomes (1)
- measure
- disease free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed colorectal cancer with liver metastasis(all patients should have the pathological report of colorectal cancer. The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. ) 2. Liver metastasis should be resected with R0 resection and to save enough normal liver tissue 3. Anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50% 4. No metastasis of other organs or lymph nodes in abdominal cavity 5. No previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months 6. Age 18 to 75 years old 7. Karnofsky performance status ≥70 8. Life expectancy of ≥3 month 9. Bilirubin level \< 1.5mg/dL 10. Serum creatinine \<1.0 times ULN 11. Absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl 12. Having signed informed consent Exclusion Criteria: 1. previous use of oxaliplatin or fluorouracil-based chemotherapy in 6 months. 2. No R0 resection or not enough normal liver tissue left 3. previous radiotherapy of target lesions 4. accompanied with unresectable other metastasis or malignant pleural fluids or ascites. 5. complete or uncompleted liver obstruction 6. peripheral neuropathy(NCI-CTC grade 1 or more) 7. mental disturbance neuropathy that influence the cognition, including brain metastasis 8. other serious disease such as uncontrollable active infection, heart infarction with 1 year, un controlled hypertension, arrhythmia with high risk, or unstable heart infarction,heart failure, coronary artery disease, myocardial infarction within the last 6 months 9. Other previous malignancy within 5 year, except non-melanoma skin cancer 10. accompany with other anti-tumor therapies,including immune therapy, intervention or injection with chemotherapeutical agents into serous cavity, or participating other clinical trials. 11. Pregnancy or lactation period
References
Publications (0)
Data not yet available
No reference posted for this study.