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

This study is currently recruiting participants.
Verified February 2008 by Peking University People's Hospital
Sponsor:
Collaborators:
Peking University
Sanofi
Information provided by:
Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT00630045
First received: February 26, 2008
Last updated: March 5, 2008
Last verified: February 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Resectable Liver Metastasis
 Drug: neoadjuvant chemotherapy with oxaliplatin and capecitabine
Procedure: resection of liver metastasis
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • disease free survival rate [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • R0 resection rate [ Time Frame: at the time of pathological report ] [ Designated as safety issue: No ]
  • survival rate and over survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • surgery related mortality [ Time Frame: peri-operation period ] [ Designated as safety issue: Yes ]
  • response rate and safety of XELOX as a neoadjuvant regimen [ Time Frame: no time frame ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 392
Study Start Date: January 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630045

Contacts
Contact: zhou jing, MD 86-10-66583821 zhoujing58@sohu.com
Contact: Xiaotian Zhang, MD 86-10-88196561 zhangxt@yahoo.com

Locations
China, Beijing
Peking University, School of Oncology Recruiting
Beijing, Beijing, China, 100036
Contact: Xiaotian Zhang, MD     86-10-88196561     zhangxt@yahoo.com    
Contact: jifang gong, MD     86-10-88196088     goodjf@163.com    
China
Peking University, People's Hospital Recruiting
Beijing, China, 100044
Contact: jing zhou, MD     86-10-66583821     zhoujing58@sohu.com    
Sponsors and Collaborators
Peking University People's Hospital
Peking University
Sanofi
Investigators
Principal Investigator: Shan Wang, MD Peking University People's Hospital, Department of General Surgery
Principal Investigator: Lin Shen, MD Peking University, School of Oncology, Department of GI Oncology
  More Information

No publications provided

Responsible Party: Yeying Jiang/Associate professor, Peking University People's Hospital,Department of General Surgery
ClinicalTrials.gov Identifier: NCT00630045     History of Changes
Other Study ID Numbers: OXALIC
Study First Received: February 26, 2008
Last Updated: March 5, 2008
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 13, 2013