Clinical Trials /

Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection

NCT04457297

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.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
trifluridine and tipiraciltrifluridine and tipiracil
PlaceboPlacebo

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

NameTypeDescriptionInterventions
trifluridine and tipiracilExperimental
  • trifluridine and tipiracil
PlaceboPlacebo Comparator
  • Placebo

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

July 16, 2020