Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients
NCT ID: NCT02376452
Last Updated: 2015-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RALIRI
Raltitrexed combined with irinotecan
Raltitrexed
2mg/m2 iv gtt, d1
Irinotecan
180 mg/m2 iv gtt, d1
FOLFIRI
5-fluorouracil,folinate combined with irinotecan
Irinotecan
180 mg/m2 iv gtt, d1
5-fluorouracil
5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
Leucovorin
400mg/m2 iv gtt,d1
Interventions
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Raltitrexed
2mg/m2 iv gtt, d1
Irinotecan
180 mg/m2 iv gtt, d1
5-fluorouracil
5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
Leucovorin
400mg/m2 iv gtt,d1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group performance status of 0 to 1
* life expectancy of ≥ 3 months
* patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
* at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
* have adequate bone marrow, hepatic, and renal function
Exclusion Criteria
* patients with symptomatic brain metastases
* active clinical severe infection
* previously received irinotecan or raltitrexed
* dihydropyrimidine dehydrogenase (DPD) enzyme adequate
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Jin Li
Fudan University Shanghai Cancer Center
Principal Investigators
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Wen Zhang
Role: PRINCIPAL_INVESTIGATOR
Medical Oncology, Fudan University Shanghai Cancer Center
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Wen Zhang
Role: CONTACT
Wenhua Li
Role: CONTACT
Facility Contacts
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Other Identifiers
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RALIRI
Identifier Type: -
Identifier Source: org_study_id
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