Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin
NCT ID: NCT02087475
Last Updated: 2019-06-05
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
360 participants
INTERVENTIONAL
2011-01-31
2024-12-31
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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Neoadjuvant therapy arm
FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles
Irinotecan
5-fluorouracil
Local radiotherapy
R0 resection
Adjuvant therapy arm
Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy
Irinotecan
5-fluorouracil
Local radiotherapy
R0 resection
Interventions
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Irinotecan
5-fluorouracil
Local radiotherapy
R0 resection
Eligibility Criteria
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Inclusion Criteria
* ECOG score: 0 or 1
* Histological confirmed of Colorectal Adenocarcinoma
* History of exposure to oxaliplatin
* With local recurrent or metastatic focus
* Tumor resectable confirmed by at less 3 hepatobiliary surgeon
* Informed content acquired
Exclusion Criteria
* Received surgery in recently 4 weeks or did not recover from surgery
* Other history of cancer in recent 5 years
* Fluorouracil allergy or dihydropyrimidine dehydrogenase defect
* Women with potential pregnancy.
18 Years
80 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Ping Lan
Professor
Principal Investigators
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Ping Lan, MD
Role: PRINCIPAL_INVESTIGATOR
Sixth Affiliated Hospital, Sun Yat-sen University
Locations
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The 6th Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SAH 5010 CRC
Identifier Type: -
Identifier Source: org_study_id
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