JCOG2014: Randomized phase III study of bi-weekly trifluridine/tipiracil plus bevacizumab vs trifluridine/tipiracil alone for chemorefractory metastatic colorectal cancer

JRCT ID: jRCTs031210544

Registered date:11/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 14/01/2022
• Target sample size: 420
• Study type: Interventional

Intervention(s)

A: FTD/TPI monotherapy
FTD/TPI (35 mg/m2 given orally twice daily on days 1-5 and 8-12 in a 28-day cycle)

B: Bi-weekly FTD/TPI+BEV combination
Bi-weekly FTD/TPI (35 mg/m2 given orally twice daily on days 1-5 in a 14-day cycle) with BEV (5 mg/kg on day1, every 2 weeks)

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival: PFS, Response proportion (Response rate: RR), Disease control rate: DCR, Adverse events, Serious adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Pathologically proven colorectal adenocarcinoma
(2) Tumor located between cecum and lower rectum (caecum [C], asending colon [A], transverse colon [T], descending colon [D], sigmoid colon [S], rectosigmoid [RS], upper rectum [Ra], lower rectum [Rb])
(3) Unresectable StageIV or recurrent colorectal cancer diagnosed by enhanced chest/abdominal/pelvic computed tomography
(4) Known RAS status
(5) Known BRAFV600E status
(6) Age>=20 years
(7) ECOG PS 0 or 1
(8) Measurable lesions based on the RECIST v1.1
(9) Refractory or intolerant to fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF therapy, anti-EGFR therapy (for tumors with wild-type RAS), BRAF inhibitor plus anti-EGFR combination (for tumors with mutant-type BRAFV600E), and immune checkpoint inhibitors (for tumors with MSI-H)
(10) No prior FTD/TPI therapy
(11) Able to take oral drugs
(12) No surgical history within 28 days prior to registration
(13) Adequate organ function within 7days prior to registration (neutrophil count>=1,200/mm3, hemoglobin>=8.0g/dL, platelet count>=75,000/mm3, total bilirubin<=1.5mg/dL, serum transaminases<=100U/L [<=200U/L for liver metastases], serum creatinine<=1.5mg/dL, urine protein<=1+ or UPCR<=2.0)
(14))With written informed consent

Exclude criteria

(1) Synchronous or metachronous active malignancies other than colorectal cancer (within 2 years)
(2) Infectious disease requiring systemic treatment
(3) Fever above 38 degree Celsius
(4) Women who are pregnant, breast feeding, or who wish to conceive. Men who wish to conceive.
(5) Severe psychological disease
(6) Continuous systemic corticosteroid or immunosuppressants
(7) Uncontrolled hypertension
(8) History of new or worsened unstable angina within 3 weeks
(9) Uncontrolled valvular heart disease, dilated cardiomyopathy or hypertrophic cardiomyopathy
(10) HCV antibody positive
(11) Active or persistent bleeding
(12) Metastasis to central nerve system
(13) Ascites, pleural effusion, or pericardial effusion with drainage within 4 weeks
(14) Chronic lung disease requiring oxygen administration
(15) Unrecovered grade 2 or higer (CTCAE ver.5.0) AEs related to previous treatment
(16) Unstable thromboembolism

Related Information

• Primary Sponsor: YAMAZAKI Kentaro
• Source(s) of Monetary Support: National Cancer Center Japan