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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00997685

Enrollment

110

Registered

2009-10-19

Start date

2009-11-30

Completion date

2015-10-31

Last updated

2009-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Potentially Resectable Liver Metastasis From CRC

Keywords

XELOX, potentially resectable liver metastasis from CRC

Brief summary

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.

Detailed description

To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer

Interventions

DRUGCapecitabine plus oxaliplatin

Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w, 4 pre-operative cycles, 4 post-operative cycles

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer	3.6 years

Secondary

Measure	Time frame
To evaluate the R0 resection rate	3.6 years
To evaluate the safety profile of XELOX peri-operative treatment	3.6 years
To investigate the response rate	3.6 years

Countries

China

Contacts

Primary ContactFeng Lin, Dr

+8613903018609

Backup ContactYong Li, Dr

yongyongsmart@yahoo.cn+8613822177479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026