Colon Cancer
Conditions
Keywords
colon cancer, Chemotherapy, adjuvant
Brief summary
This study sets up the final study end point and three detailed goals as the following. 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
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 * 2,400mg/m2 over 46 hours
Interventions
DRUGtiming to initiate the adjuvant FOLFOX 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
Sponsors
Kyungpook National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Eligibility rule of enrollment * 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
* An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate | up to 3 years after operation | A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| short-term cumulative surgery-related complications during chemotherapy | up to 26 weeks after operation | A comparison of the postoperative recovery variables, the postoperative complications and mortality |
| side effects of chemotherapy | during chemotherapy period | check Anemia, Leukopenia, Neutropenia, Thrombocytopenia, Edema, Fever, Insomnia, Asthenia, Anorexia, Nausea, Vomiting, Constipation, Diarrhea, Hand foot syndrome, Dyspepsia, Creatinine, AST, ALT, Bilirubin, abdominal pain, GI bleeding, diarrhea |
Countries
South Korea
Contacts
STUDY_CHAIRJun Seok Park, M.D.Ph.D
Kyunpook National Univercity Medical Center
Outcome results
None listed