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Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection
Phase 3 trial testing trifluridine and tipiracil in Colorectal Neoplasms in 243 participants. Completed in 18 July 2024.
| Lead sponsor | National Cancer Center Hospital East |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 243 |
| Start date | 8 July 2020 |
| Primary completion | 18 July 2024 |
| Estimated completion | 18 July 2024 |
| Sites | 39 locations across Taiwan, Japan |
National Cancer Center Hospital East
20 and older, any sex, with Colorectal Neoplasms or Trifluridine and Tipiracil. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | 9.30 | 7.82 – 10.84 |
| Placebo | 5.55 | 4.17 – 6.47 |
This rate is defined as the proportion of subjects who became negative for ctDNA at the test immediately after completion of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | 17.2 | 11.0 – 25.1 |
| Placebo | 12.4 | 7.1 – 19.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | 9.30 | 7.82 – 10.84 |
| Placebo | 5.55 | 4.17 – 6.47 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | NA | NA – NA |
| Placebo | 37.26 | NA – NA |
This rate had calculated for each eligible subject in accordance with the following equation: Treatment completion rate (%) = number of treatment courses completed/6 × 100
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | 77.87 | ± 30.26 |
| Placebo | 78.79 | ± 25.46 |
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/mor
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | 0.00 | ± 22.71 |
| Placebo | 4.36 | ± 22.39 |
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | -1.10 | ± 13.64 |
| Placebo | 1.13 | ± 9.47 |
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | -3.33 | ± 14.27 |
| Placebo | -3.33 | ± 12.57 |
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | 4.22 | ± 14.86 |
| Placebo | 0.64 | ± 13.84 |
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | 0.20 | ± 15.75 |
| Placebo | 2.56 | ± 17.49 |
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | -2.55 | ± 12.99 |
| Placebo | 1.28 | ± 12.95 |
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | 3.14 | ± 16.76 |
| Placebo | -2.74 | ± 16.90 |
| Group | Value | 95% CI |
|---|---|---|
| Trifluridine and Tipiracil | 4.12 | ± 1.28 |
| Placebo | 10.26 | ± 7.96 |
Time frame: Up to 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Trifluridine and Tipiracil | Placebo |
|---|---|---|---|
| Ileus | Gastrointestinal disorders | — | — |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Cerebral haemorrhage | Nervous system disorders | — | — |
| Cerebral infarction | Nervous system disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Aspiration | Respiratory, thoracic and mediastinal disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Reaction | System | Trifluridine and Tipiracil | Placebo |
|---|---|---|---|
| Neutrophil count decreased | Investigations | — | — |
| White blood cell count decreased | Investigations | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Malaise | General disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Pyrexia | General disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Ileus, Adenocarcinoma gastric, Cerebral haemorrhage, Cerebral infarction, Myocardial infarction, Aspiration, Intestinal obstruction.
Data from ClinicalTrials.gov NCT04457297 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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