TRUSTY

JRCT ID: jRCTs031180122

Registered date:13/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: unresectable advanced or recurrent colorectal cancer
• Date of first enrollment: 02/10/2017
• Target sample size: 524
• Study type: Interventional

Intervention(s)

<Fluoropyrimidine+irinotecan+bevacizumab treatment arm>
Prior to enrollment, investigator or subinvestigator select one of the following scheduled regimens for each patient.

1.FOLFIRI+bevacizumab therapy
Bevacizumab 5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1. After that,
irinotecan 150mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1. At the same time, levofolinate 200mg/ m^2 is given as an infusion of the course of 2 hours on Day1. After that, fluorouracil 400 mg/ m^2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/ m^2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met.

2. S-1+irinotecan+bevacizumab therapy with a 3-week cycle
Bevacizumab 7.5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1.
After that, irinotecan 150 mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1.
S-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met.

3. S-1+irinotecan+bevacizumab therapy with a 4-week cycle
Bevacizumab 5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1 and Day 15.
After that, irinotecan 100 mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1 and Day 15.
S-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 14-day rest. Each cycle was 28 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met.

<Trifluridine/tipiracil+bevacizumab treatment arm>
Bevacizumab 5 mg/kg was given as an intravenous infusion over the course of 30 min on Day 1 and Day 15.
Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met.

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Quality of life, proportion of patients receiving post-study treatment, Progression-free survival, Time to treatment failure, Time to post-treatment failure, Overall Response rate, Disease Control Rate and Safety

Key inclusion & exclusion criteria

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

Include criteria

(1) A histopathologically or cytologically confirmed diagnosis of curatively unresectable advanced adenocarcinoma of the colon or rectum for which RAS mutation status has been confirmed on RAS mutation analysis
(2) Unresectable advanced adenocarcinoma of the colon or rectum with refractory to first-line treatment with a fluoropyrimidine (5-FU/l-LV, capecitabine, S-1) + oxaliplatin with bevacizumab or an anti-EGFR antibody (cetuximab or panitumumab: only RAS wild-type tumors)
(3) An age of at least 20 years at the time of enrollment
(4) An ECOG performance status of 0 or 1
(5) Possible to orally administer drugs
(6) Have evaluable lesions on CT, MRI, etc. confirmed within 28 days before enrollment (measurable lesions not required)
(7) Main organ functions maintained on examinations performed within 14 days before enrollment
(8) Written informed consent to participate in the study obtained

Exclude criteria

(1)Patients who have severe complication and past history
(2) Patients who received anticancer therapy within less than 14 days before enrollment to this study
(3) Pregnant women, nursing mothers, women with positive by pregnancy test or who do not prevent pregnancy, men who desire to bear their children.
(4) Is judged by the investigator or subinvestigator to be unsuitable as a subject in this study

Related Information

• Primary Sponsor: Kuboki Yasutoshi
• Secondary Sponsor: Yoshino Takayuki,Taiho Pharmaceutical Co., Ltd.,Taiho Pharmaceutical Co., Ltd.
• Secondary ID(s): JapicCTI-173618