Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis

March 5, 2008 updated by: Peking University People's Hospital

A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis

This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Liver metastasis is the most important prognostic factor of colorectal cancer. Reasonable multidisciplinary therapy might improve the prognosis of patients with liver metastasis. Surgery has been the first choice under such situation. Recently, neoadjuvant chemotherapy has also shown its value in unresectable liver metastasis, for it can increase the chance of R0 resection and give some clues to chemosensitivity of agents. However, for those resectable lesions, the role and safety of neoadjuvant chemotherapy has yet to be confirmed. so we design this study.

Study Type

Interventional

Enrollment (Anticipated)

392

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
        • Recruiting
        • Peking University, People's Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100036
        • Recruiting
        • Peking University, School of Oncology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
2~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis
Drug: neoadjuvant chemotherapy with oxaliplatin and capecitabine
oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
Procedure: resection of liver metastasis
surgery with the aim of R0 resection
Active Comparator: 2
no neoadjuvant chemotherapy, resect the liver metastasis directly
Procedure: resection of liver metastasis
surgery with the aim of R0 resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease free survival rate
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
R0 resection rate
Time Frame: at the time of pathological report
at the time of pathological report
survival rate and over survival
Time Frame: 5 year
5 year
surgery related mortality
Time Frame: peri-operation period
peri-operation period
response rate and safety of XELOX as a neoadjuvant regimen
Time Frame: no time frame
no time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Peking University
Sanofi

Investigators

  • Principal Investigator: Lin Shen, MD, Peking University, School of Oncology, Department of GI oncology
  • Principal Investigator: Shan Wang, MD, Peking University People's Hospital, Department of General Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2008

Last Update Submitted That Met QC Criteria

March 5, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXALIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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