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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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Potentially Resectable Liver Metastasis From CRC, Colorectal Cancer

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3.6 years

Safety Issue:

No

Principal Investigator

Feng Lin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital

Authority:

China: Ethics Committee

Study ID:

ML22298

NCT ID:

NCT00997685

Start Date:

November 2009

Completion Date:

October 2015

Related Keywords:

  • Potentially Resectable Liver Metastasis From CRC
  • Colorectal Cancer
  • XELOX
  • potentially resectable liver metastasis from CRC
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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