search
Back to results

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

Primary Purpose

Colorectal Cancer, Resectable Liver Metastasis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
neoadjuvant chemotherapy with oxaliplatin and capecitabine
resection of liver metastasis
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University, School of OncologyRecruiting
  • Peking University, People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

2~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis

no neoadjuvant chemotherapy, resect the liver metastasis directly

Outcomes

Primary Outcome Measures

disease free survival rate

Secondary Outcome Measures

R0 resection rate
survival rate and over survival
surgery related mortality
response rate and safety of XELOX as a neoadjuvant regimen

Full Information

First Posted
February 26, 2008
Last Updated
March 5, 2008
Sponsor
Peking University People's Hospital
Collaborators
Peking University, Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00630045
Brief Title
Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis
Official Title
A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Peking University People's Hospital
Collaborators
Peking University, Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Resectable Liver Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
392 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
2~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis
Arm Title
2
Arm Type
Active Comparator
Arm Description
no neoadjuvant chemotherapy, resect the liver metastasis directly
Intervention Type
Drug
Intervention Name(s)
neoadjuvant chemotherapy with oxaliplatin and capecitabine
Intervention Description
oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
Intervention Type
Procedure
Intervention Name(s)
resection of liver metastasis
Intervention Description
surgery with the aim of R0 resection
Primary Outcome Measure Information:
Title
disease free survival rate
Time Frame
3 year
Secondary Outcome Measure Information:
Title
R0 resection rate
Time Frame
at the time of pathological report
Title
survival rate and over survival
Time Frame
5 year
Title
surgery related mortality
Time Frame
peri-operation period
Title
response rate and safety of XELOX as a neoadjuvant regimen
Time Frame
no time frame

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. ) Liver metastasis should be resected with R0 resection and to save enough normal liver tissue Anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50% No metastasis of other organs or lymph nodes in abdominal cavity No previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months Age 18 to 75 years old Karnofsky performance status ≥70 Life expectancy of ≥3 month Bilirubin level < 1.5mg/dL Serum creatinine <1.0 times ULN Absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl Having signed informed consent Exclusion Criteria: previous use of oxaliplatin or fluorouracil-based chemotherapy in 6 months. No R0 resection or not enough normal liver tissue left previous radiotherapy of target lesions accompanied with unresectable other metastasis or malignant pleural fluids or ascites. complete or uncompleted liver obstruction peripheral neuropathy(NCI-CTC grade 1 or more) mental disturbance neuropathy that influence the cognition, including brain metastasis 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 Other previous malignancy within 5 year, except non-melanoma skin cancer accompany with other anti-tumor therapies,including immune therapy, intervention or injection with chemotherapeutical agents into serous cavity, or participating other clinical trials. Pregnancy or lactation period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhou jing, MD
Phone
86-10-66583821
Email
zhoujing58@sohu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaotian Zhang, MD
Phone
86-10-88196561
Email
zhangxt@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shan Wang, MD
Organizational Affiliation
Peking University People's Hospital, Department of General Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Organizational Affiliation
Peking University, School of Oncology, Department of GI Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University, School of Oncology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaotian Zhang, MD
Phone
86-10-88196561
Email
zhangxt@yahoo.com
First Name & Middle Initial & Last Name & Degree
jifang gong, MD
Phone
86-10-88196088
Email
goodjf@163.com
Facility Name
Peking University, People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jing zhou, MD
Phone
86-10-66583821
Email
zhoujing58@sohu.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs