None listed
Conditions
Interventions
Drug : This randomized phase 2 clinical trial aims to evaluate the effect of the Bevacizumab/Cetuximab+Irinotecan group compared to the
Bevacizumab/Cetuximab+5-fluorouracil/Leucovorin group as mainten
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who voluntarily agreed in writing to participate in the study 2. Over 19 years of age 3. Histologically or cytologically confirmed metastatic or recurrent colorectal cancer patients 4. Bevacizumab or cetuxiamb + FOLFIRI as first-line anticancer therapy for a minimum of 8 cycles and a maximum of 16 cycles Patients who have been treated and have not progressed (if the subject received adjuvant chemotherapy after radical surgery for colorectal cancer, If disease recurs during adjuvant chemotherapy or within 6 months of completing adjuvant chemotherapy, adjuvant chemotherapy is the first line It is considered palliative chemotherapy.) 5. If you have a lesion that can be evaluated by RECIST 1.1 (not necessarily a measurable lesion) 6. ECOG performance status is 0~2 7. Adequate bone marrow function ANC =1,000/µL, platelets =75,000/µL, Hb =8.0g/dL (requires intermittent transfusion You can participate in the study if 8. Adequate liver function [total bilirubin =1.5xULN, ALT and ALT =3xULN In case of liver failure: total bilirubin 3 x UNL, AST and ALT 5 x UNL)] 9. Adequate renal function serum creatinine =1.5xULN or creatinine clearance rate 50 ml/min (Cockroft)] 10. A person who understands the contents of the clinical trial, is cooperative with the progress of the trial, and is judged to be able to participate until the end of the study
Exclusion criteria
Exclusion criteria: 1. Cases where R0 or R1 resection of metastatic colorectal cancer was performed before or during first-line chemotherapy (only the primary site Resection or R2 resection is not an exclusion criterion) 2. 70% of the recommended dose of either irinotecan or 5 FU at the time of the last round of induction therapy immediately before study enrollment (However, when switching to maintenance therapy, restore the dose of the drug to 70% or more of the recommended dose It is not an exclusion criterion if the researcher judges that it can be started) 3. Clinically significant heart disease [unstable angina requiring medication, symptomatic coronary artery disease, New York Heart Association (NYHA) Grade II or higher congestive heart failure or significant cardiac arrhythmia, or acute including myocardial infarction within the past 6 months coronary artery syndrome] 4. Active viral infection such as HIV (However, if a prophylactic antiviral agent is used for HBV can be registered) 5. Uncontrolled serious infections or other uncontrolled comorbidities 6. Symptomatic Inflammatory Bowel Disease 7. History of allografts requiring immunosuppressive therapy 8. Completely excised basal cell carcinoma of the skin, completely excised cervical carcinoma in situ, treatment including surgery History of other malignancies identified within the past 2 years, excluding thyroid cancer that has been terminated 9. Other serious or unstable pre-existing medical or mental problems of the subject during the study If the investigator determines that safety may be threatened
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with progression-free status after secondary chemotherapy at one year from random assignment 1yr-PFS2 rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | — |
Countries
Korea, Republic of
Contacts
Public ContactYeon Hee Lee
National Cancer Center
Outcome results
None listed