FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients
NCT ID: NCT02935764
Last Updated: 2016-10-17
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
PHASE3
164 participants
INTERVENTIONAL
2016-10-31
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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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
IRINOTECAN
irinotecan
Irinotecan
180 mg/m2 iv gtt, d1
Interventions
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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 2
* 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
* 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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Weijian Guo
Vice Director of Department of Medical Oncology, Clinical Professor
References
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Zhang X, Duan R, Wang Y, Liu X, Zhang W, Zhu X, Chen Z, Shen W, He Y, Wang HQ, Huang M, Wang C, Zhang Z, Zhao X, Qiu L, Luo J, Sheng X, Guo W. FOLFIRI (folinic acid, fluorouracil, and irinotecan) increases not efficacy but toxicity compared with single-agent irinotecan as a second-line treatment in metastatic colorectal cancer patients: a randomized clinical trial. Ther Adv Med Oncol. 2022 Jan 13;14:17588359211068737. doi: 10.1177/17588359211068737. eCollection 2022.
Other Identifiers
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FDZL-FCI
Identifier Type: -
Identifier Source: org_study_id
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