- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00869271
Postoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer
Postoperative folfox4 Only vs folfox4 Plus TAC in the Treatment Unresectable Liver Metastasis of Colorectal Cancer: a Randomized,Prospective,Control Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Zhongshan Hospital, Fudan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age < 75 years with histologically proven adenocarcinoma of the colon or rectum
- no severe major organ dysfunction
- WHO performance status of 0 or 1
- no prior cancer therapy
- with measurable unresectableliver metastasis
- without other metastasis
Exclusion Criteria:
- age >= 75
- severe major organ dysfunction
- WHO performance status of >1
- prior cancer therapy
- with other metastasis
Study Plan
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
folfox4 chemotherapy was done within 28 days after primary surgery.
Per 3 weeks, patients will receive one cycle.
After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc.
Then begin folfox4 again.
|
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg folfox4 Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again. |
Active Comparator: 2
folfox4 chemotherapy was done within 28 days after primary surgery.
Per 3 weeks, patients will receive one cycle.
|
folfox4 Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 5 years after diagnosis
|
5 years after diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival
Time Frame: 5 years after diagonsis
|
5 years after diagonsis
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Liver Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Liver Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
Other Study ID Numbers
- 2009-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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