Early Commencement of Adjuvant Chemotherapy for Colon Cancer
NCT ID: NCT01460589
Last Updated: 2022-12-22
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
440 participants
INTERVENTIONAL
2011-11-30
2024-12-31
Brief Summary
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The main objective of study: This trial is done to assess the safety and benefit of early adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional commencement after 2weeks for treatment of patients with colon cancer.
Detailed goal of study:
The primary endpoint: This study is designed to assess whether early commencement of adjuvant chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate.
The secondary endpoint: This study aims to compare short-term cumulative complications between early and conventional commencement of adjuvant chemotherapy after laparoscopic resection of colon cancer. This study will also assess the quality of life and side effects of chemotherapy.
Detailed Description
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* day1: Oxaliplatin 85mg/m2
* day1: Leucovorin 200mg/m2
* day1: 5-FU 400mg/m2 IV bolus
* 2,400mg/m2 over 46 hours
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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early commencement
Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery
timing to initiate the adjuvant chemotherapy
Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours
conventional commencement
Individuals who initiate the adjuvant chemotherapy after 14 days after surgery
timing to initiate the adjuvant chemotherapy
Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours
Interventions
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timing to initiate the adjuvant chemotherapy
Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rectal adenocarcinoma that were 15 cm or more from the anal verge
* pathologically diagnosed stage II or III disease
* patients who meet the discharge criteria within 10days after surgery
* Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography
Exclusion Criteria
* A past history of chemotherapy
* tumor with obstruction or perforation
* tumor with distant metastases
* synchronous tumor
* relative or absolute contraindications of chemotherapy
* Recent MI, CVA, nitrate medication
* Severe cardiovascular disease, psychiatric disease
* Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
* Renal dysfunction (Cr ≥2mg/dl)
* The concurrent presence of other severe medical diseases
18 Years
70 Years
ALL
No
Sponsors
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Kyungpook National University Hospital
OTHER
Responsible Party
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Gyu-Seog Choi
Director, Head of colorectal cancer center, Principal Investigator, Professor
Principal Investigators
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Gyu seog Choi, M.D.
Role: STUDY_CHAIR
Kyunpook National Univercity Medical Center
Locations
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Kyungpook National University Hospital
Daegu, , South Korea
Gyu seog Choi
Daegu, , South Korea
Countries
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Other Identifiers
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KNUHCRC004
Identifier Type: -
Identifier Source: org_study_id