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New Adjuvant Chemotherapy of Non Resectable Liver Metastasis of Colorectal Cancer Without Bleeding, Obstruction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Fudan University.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
The First Affiliated Hospital with Nanjing Medical University
Shanghai 6th People's Hospital
Shanghai 9th People's Hospital
Ruijin Hospital
Information provided by (Responsible Party):
Xu jianmin, Fudan University
ClinicalTrials.gov Identifier:
NCT01307878
First received: March 2, 2011
Last updated: December 10, 2013
Last verified: December 2013
  Purpose
Evaluation of new adjuvant chemotherapy for unresectable liver metastasis of colorectal cancer without bleeding, obstruction, etc.

Condition Intervention Phase
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Chemotherapy; Maternal, Affecting Fetus
Drug: chemotherapy ± targeted therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of New Adjuvant Chemotherapy of Non Resectable Liver Metastasis of Colorectal Cancer Without Bleeding, Obstruction

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • liver metastasis resection rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • recurrence rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm A
chemotherapy ± targeted therapy before resection of primary colorectal cancer
Drug: chemotherapy ± targeted therapy
FOLFOX 6 ± targeted therapy
No Intervention: arm B
resected the primary colorectal cancer and then given chemotherapy ± targeted therapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 - 75 years old
  • colorectal adenocarcinoma pathologically
  • without any chemotherapy or radiotherapy
  • unresectable liver metastasis and without other metastasis
  • resectable colorectal cancer
  • suitable for chemotherapy
  • agreed by patients

Exclusion Criteria:

  • age below 18 years old or greater than 75 years old
  • haven't pathological diagnosis of colorectal adenocarcinoma
  • with any chemotherapy or radiotherapy
  • resectable liver metastasis or without other metastasis
  • unresectable colorectal cancer
  • unsuitable for chemotherapy
  • not agreed by patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307878

Locations
China, Shanghai
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
The First Affiliated Hospital with Nanjing Medical University
Shanghai 6th People's Hospital
Shanghai 9th People's Hospital
Ruijin Hospital
  More Information

Responsible Party: Xu jianmin, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT01307878     History of Changes
Other Study ID Numbers: 20110101 
Study First Received: March 2, 2011
Last Updated: December 10, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on December 05, 2016