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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01023633 |
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Date of registration:
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01/12/2009 |
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Primary sponsor: |
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Public title:
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OPTIMOX1 in Chinese mCRC Patients
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Scientific title:
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A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01023633 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Yongqian Shu, MD |
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Address:
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Telephone:
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86 25 83718836 |
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Email:
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shuyongqian@csco.org.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with histologically confirmed adenocarcinoma of the colon or rectum
- Unresectable metastases
- At least one bidimensionally measurable lesion of = 1 cm
- No previous chemotherapy for metastatic disease; Completed at least more than 1 year
oxaliplatin therapy for adjuvant treatment
- 18-75 years old
- ECOG 0-2
- Life expectancy greater than 3 months
- Hemogram: WBC=4.0 X109/L, ANC =2 X109/L, PLT =100 X109/L, Hb =90g/L,
- Adequate Renal Function
- Adequate Liver Function
- Signed informed consent before the treatment
Exclusion Criteria:
- Patients with previous oxaliplatin based adjuvant chemotherapy within 1 Year
- Completely or partially bowel obstruction
- Presence of peripheral neuropathy (CTC>grade I)
- Severe mental disorder
- CNS metastasis
- With other severe disease: uncontrolled active infectious disease, uncontrolled
hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia,
unstable angina
- With other malignant disease previously or concurrently
- Receive other anti-tumor treatment
- Pregnant or lactating women, or women of child bearing potential without
contraceptive method.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Drug: Oxaliplatin, LV, 5-FU
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Primary Outcome(s)
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DDC: Duration of Disease Control
[Time Frame: Oct2012]
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Secondary Outcome(s)
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OS, RR, PFS, DCR, safety,
[Time Frame: Oct 2015]
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Secondary ID(s)
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Oxali04882
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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