This trial is a randomized, double-blind, multinational Phase III study to evaluate the efficacy and safety of preemptive treatment with FTD/TPI compared with administration of placebo as follow-up, which is the standard of care, in patients who underwent curative resection of colorectal cancer and then tested positive for ctDNA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
243
Trifluridine and tipiracil will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.
Placebo will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.
Disease-free Survival 1 (DFS1)
The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, the first development of a secondary colorectal cancer lesion other than a relapse and death from any cause.
Time frame: Up to 3 years
Rate of Conversion to Negative ctDNA
This rate is defined as the proportion of subjects who became negative for ctDNA at the test immediately after completion of study treatment.
Time frame: Up to 2 years
Disease-free Survival 2 (DFS2)
The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, development of a cancer lesion other than a relapse (secondary cancer), and death from any cause. For survives with no evidence of recurrence, DFS2 data will be censored at the last imaging date of confirmed no recurrence. Subjects for which no imaging have been performed, DFS2 data will be censored at the date of enrollment.
Time frame: Up to 3 years
Overall Survival (OS)
The time from the date of enrollment to the date of death from any cause. In surviving subjects, the last date of confirmation of survival will be treated as the end of this period. In subjects lost to follow-up, the last date of confirmation of survival before loss to follow-up will be treated as the end of this period.
Time frame: Up to 3 years
Treatment Completion Rate
This rate had calculated for each eligible subject in accordance with the following equation: Treatment completion rate (%) = number of treatment courses completed/6 × 100
Time frame: Up to 3 years
QOL (Week 24 Only)
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Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Shikoku Cancer Center
Matsuyama, Ehime, Japan
University of Fukui Hospital
Yoshida, Fukui, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu, Fukuoka, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
...and 29 more locations
Measure Description: Quality of Life was assessed using two validated instruments: EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) evaluates cancer-specific HRQoL across domains: Global Health Status/QoL (range: 0-100, higher = better global health/QoL), Functional Scales (Physical, Role, Emotional, Cognitive, Social; each range: 0-100, higher = better functioning), Symptom Scales (Fatigue, Nausea/vomiting, Pain, Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties): each 0-100 (higher = worse/more severe symptoms). Scores are linearly transformed; subscales are reported individually (not summed). EQ-5D-5L (EuroQOL 5-Dimension 5-Level) measures general health across five dimensions: Index Score (range: -1.000 to 1.000, higher = better health), Visual Analogue Scale (VAS) (range: 0-100, higher = better health). Unit of Measure: scores on a scale. Note: Only Week 24 results are presented.
Time frame: Up to 1 year