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Sponsors and Collaborators: |
Peking University People's Hospital Peking University Sanofi-Aventis |
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Information provided by: | Peking University People's Hospital |
ClinicalTrials.gov Identifier: | NCT00630045 |
This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .
Condition | Intervention | Phase |
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Colorectal Cancer Resectable Liver Metastasis |
Drug: neoadjuvant chemotherapy with oxaliplatin and capecitabine Procedure: resection of liver metastasis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis |
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 |
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1: Experimental
2~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis
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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
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2: Active Comparator
no neoadjuvant chemotherapy, resect the liver metastasis directly
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Procedure: resection of liver metastasis
surgery with the aim of R0 resection
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: zhou jing, MD | 86-10-66583821 | zhoujing58@sohu.com |
Contact: Xiaotian Zhang, MD | 86-10-88196561 | zhangxt@yahoo.com |
China | |
Peking University, People's Hospital | Recruiting |
Beijing, China, 100044 | |
Contact: jing zhou, MD 86-10-66583821 zhoujing58@sohu.com | |
Peking University, School of Oncology | Recruiting |
Beijing, China, 100036 | |
Contact: Xiaotian Zhang, MD 86-10-88196561 zhangxt@yahoo.com | |
Contact: jifang gong, MD 86-10-88196088 goodjf@163.com |
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 |
Responsible Party: | Peking University People's Hospital,Department of General Surgery ( Yeying Jiang/Associate professor ) |
Study ID Numbers: | OXALIC |
Study First Received: | February 26, 2008 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00630045 |
Health Authority: | China: State Food and Drug Administration |
Capecitabine Liver Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Liver neoplasms Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Liver Neoplasms Oxaliplatin Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Neoplastic Processes Neoplasms Antimetabolites, Antineoplastic Pathologic Processes |
Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |