Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer Prospective Study in Taiwan

July 3, 2024 updated by: Chang Gung Memorial Hospital

The Efficacy of Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer: Multi-center Prospective Study in Taiwan

Primary Endpoint : To evaluate the Disease control rate (DCR)

Secondary Endpoints:

To evaluate the Progression-free survival (PFS), Overall survival(OS) and Safety profile

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

70 Per-protocol patients Plan to recruit 70 evaluable patients (With expected dropout rate of 22%, the sample size would be 90 subjects.) Simon's two-stage design (Simon, 1989) will be used. The null hypothesis that the true response rate is 0.45 will be tested against a one-sided alternative. In the first stage, 42 patients will be accrued. If there are 19 or fewer responses in these 42 patients, the study will be stopped. Otherwise, 28 additional patients will be accrued for a total of 70. The null hypothesis will be rejected if 39 or more responses are observed in 70 patients. This design yields a type I error rate of 0.05 and power of 0.8 when the true response rate is 0.6.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Linkou, Taiwan
        • Recruiting
        • Chang-Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the metastatic colorectal cancer;
  2. Previously treated with fluorouracil-, oxaliplatin-, and irinotecan-based chemotherapy, and anti-vascular endothelial growth factor (anti-VEGF) biological therapy;
  3. The RAS wild-type patients need to receive anti-EGFR therapy;
  4. Presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of : 10mm by CT scan, MRI and PET-CT(no less than double the slice thickness and a minimum of 10mm)(according to RECIST guideline version 1.1);
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2;
  6. Investigators prescribe Lonsurf® for metastatic colorectal cancer patients who had prior treatment with Anti-VEGF and Anti-EGFR agent on routine basis. Depending on RAS status, patients with RAS mutant receive Lonsurf® as 3rd line treatment, those with RAS wild type receive Lonsurf® as 3rd/4th line treatment;
  7. Patients received either oxaliplatin or irinotecan.

Exclusion Criteria:

  1. Patients previously received Lonsurf® (Trifluridine／Tipiracil) or regorafenib;
  2. With active central nervous system (CNS) metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth);
  3. With clinically significant gastrointestinal hemorrhage;
  4. Previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years;
  5. The patient at high risk from treatment complications including but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, uncontrolled diabetes, liver or renal failure and psychiatric illness or social situation that would preclude study compliance;
  6. Active infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: trifluridine / tipiracil + Chemotherapy

trifluridine / tipiracil 35 mg/m2 PO twice daily on days 1-5 and day 6-14 off

combination with chemotherapy (choose one) : oxaliplatin 85mg/m2 IV on day 1 every 14 days or irinotecan 100mg/m2 IV on day 1 every 14 days.
Drug: Trifluridine/tipiracil

Trifluridine/tipiracil 35 mg/m2 PO twice daily on days 1-5 and day 6-14 off

(choose one combination) : oxalipatin 85mg/m2 IV on day 1 every 14 days or irinotecan 100mg/m2 IV on day 1 every 14 days.

Other Names:
  • (choose one combination) : oxalipatin or irinotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: Tumor response will be judged according to RECIST v 1.1 criteria within every 8 weeks(± 2 week) in treatment period. The evaluation period is up to 24 months from the date of ICF is signed to first recorded progress or death whichever occurs first.
The endpoints Disease Control Rate (DCR) is defined as the proportion of patients in whom the best overall response is determined as complete response (CR), partial response (PR) or stable disease (SD).
Tumor response will be judged according to RECIST v 1.1 criteria within every 8 weeks(± 2 week) in treatment period. The evaluation period is up to 24 months from the date of ICF is signed to first recorded progress or death whichever occurs first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: The evaluation period is up to 24 months from the date of ICF is signed to the date of first recorded progress.
Progression-free survival (PFS) refers to the first treatment of trifluridine/tipiracil to disease progression or death.
The evaluation period is up to 24 months from the date of ICF is signed to the date of first recorded progress.
Overall survival(OS)
Time Frame: The evaluation period is up to 48 months from the date of ICF is signed to the date of death.
Overall survival (OS) is defined from the first treatment of Lonsurf® to death.
The evaluation period is up to 48 months from the date of ICF is signed to the date of death.
Safety profile
Time Frame: The evaluation period is up to 24 months from all adverse events occurring between the first drug intake and 30 days (inclusive) after the last administration of trial medication will be collected.
All adverse events (AEs) will be summarized and listed. All adverse events occurring between the first drug intake and 30 days (inclusive) after the last administration of trial medication will be collected, and graded according to the common terminology criteria for adverse events (CTCAE) version 5.00.
The evaluation period is up to 24 months from all adverse events occurring between the first drug intake and 30 days (inclusive) after the last administration of trial medication will be collected.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Hung-Chih Hsu, Chang Gung Memorial Hospital, Linkou, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200069A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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