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Trial Title:
Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer Prospective Study in Taiwan
NCT ID:
NCT06495463
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Trifluridine
Irinotecan
Conditions: Keywords:
trifluridine/tipiracil
combination chemotherapy
metastatic colorectal cancer
irinotecan
oxaliplatin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
trifluridine / tipiracil 35 mg/m2 PO twice daily on days 1-5 and day 6-14 off
Chemotherapy (choose one) :
oxaliplatin 85mg/m2 IV on day 1 every 14 days or irinotecan 100mg/m2 IV on day 1 every 14
days.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trifluridine/tipiracil
Description:
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.
Arm group label:
trifluridine / tipiracil + Chemotherapy
Other name:
(choose one combination) : oxalipatin or irinotecan
Summary:
Primary Endpoint : To evaluate the Disease control rate (DCR)
Secondary Endpoints:
To evaluate the Progression-free survival (PFS), Overall survival(OS) and Safety profile
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chang-Gung Memorial Hospital, Linkou
Address:
City:
Linkou
Country:
Taiwan
Status:
Recruiting
Start date:
March 19, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06495463
https://www.hpa.gov.tw/Pages/List.aspx?nodeid=269
