Description:
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.
Title
- Brief Title: Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection
- Official Title: A Randomized, Double-Blind, Phase III Study Comparing FTD/TPI Therapy Versus Placebo in Patients Who Are Positive for Blood Circulating Tumor DNA After Curative Resection of Colorectal Cancer
Clinical Trial IDs
- ORG STUDY ID:
EPOC 1905
- SECONDARY ID:
JapicCTI-205363
- NCT ID:
NCT04457297
Conditions
- Colorectal Neoplasms
- Trifluridine and Tipiracil
- Circulating Tumor DNA
Interventions
Drug | Synonyms | Arms |
---|
trifluridine and tipiracil | | trifluridine and tipiracil |
Placebo | | Placebo |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
trifluridine and tipiracil | Experimental | | - trifluridine and tipiracil
|
Placebo | Placebo Comparator | | |
Eligibility Criteria
Inclusion Criteria:
1. Patients who have been histopathologically diagnosed with colorectal adenocarcinoma
2. Patients who have undergone radical curative resection of the primary and metastatic
tumors
3. Patients with colon cancer of Stage III based on final findings (T any N1/2 M0) (UICC
TNM Classification, 8th Edition) who have a past history of standard postoperative
chemotherapy
4. Patients who tested positive for ctDNA by an analysis of blood samples using
SignateraTM within 2 months prior to enrollment
5. Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans,
etc.
6. Patients who are capable of oral ingestion
7. Patients aged 20 years or older at the time of informed consent
8. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
0 or 1
9. Patients who have no severe disorder in major organs (such as the bone marrow, heart,
lungs, liver, and kidneys) and meet the following criteria (Data obtained most
recently and within 14 days of the date of enrollment will be used for enrollment.
Data obtained 2 weeks before the date of enrollment, on the same day of the week as
the enrollment date, may be used for enrollment.)
- Neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 8.0 g/dL
- Serum creatinine ≤ 1.5 mg/dL
- Total bilirubin < 1.5 mg/dL
- ALT and AST ≤ 100 U/L
10. Patients with no diarrhea or stomatitis of Grade 2 or severer according to Common
Terminology Criteria for Adverse Events (CTCAE) v5.0
11. Patients who voluntarily gave written consent to participate in the trial after
receiving a thorough explanation of the trial before enrolling in the trial
Exclusion Criteria:
1. Patients with a history of treatment with FTD/TPI
2. Patients with a history of treatment with 2 or more regimens of postoperative adjuvant
chemotherapy (Preoperative chemotherapy will not be counted as a regimen.)
3. Patients with a past history of a malignant tumor
4. Patients with a local or systemic active infection requiring intervention
5. Patients who are positive for HBs antigen or positive for HCV antibody
6. Patients who are positive for HIV antibody (Patients who have not been tested for HIV
antibody may be enrolled.)
7. Patients with poorly controlled infections or diabetes
8. Patients with a past history of interstitial lung diseases (such as interstitial
pneumonia and pulmonary fibrosis) requiring treatment or extensive findings of these
diseases on CT
9. Patients with a serious complication
10. Patients who have been receiving systemic administration (oral or intravenous) of
steroids (for 2 weeks or more at a dose of the equivalent of ≥ 10 mg/day of
prednisolone)
11. Patients for whom enrollment in the trial is difficult because of clinically
problematic psychiatric disorders
12. Pregnant or lactating women
13. Patients with reproductive potential who do not wish to use adequate contraceptive
measures during the period of participation in the trial and during the contraception
period
14. Patients who are judged by the attending physician to be ineligible for enrollment in
the trial for other reasons
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease-free survival 1 (DFS1) |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, development of a secondary colorectal cancer lesion other than a relapse and death from any cause. |
Secondary Outcome Measures
Measure: | Rate of Conversion to Negative ctDNA |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | This rate is defined as the proportion of subjects who became negative for ctDNA at the test immediately after completion of study treatment. |
Measure: | Disease-free survival 2 (DFS2) |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | 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. In surviving subjects who have not been judged to have a relapse, the last date of survival with confirmation of no relapse be treated as the end of this period. |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | 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. |
Measure: | Incidence of Adverse Events |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | For each of the AEs due to the following study treatment, the frequency of cases with the worst grade in all courses according to CTCAE v5.0 will be calculated using all treated patients as the denominator. |
Measure: | Treatment Completion Rate |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | This rate will be calculated for each eligible subject in accordance with the following equation. Treatment completion rate (%) = number of treatment courses completed/6 × 100 |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | National Cancer Center Hospital East |
Trial Keywords
- Colorectal Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Antineoplastic Agents
- trifluridine and tipiracil
Last Updated
August 23, 2021