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

NCT06495463 | Recruiting

• 1 other identifier: 202200069A3
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Metastatic Colorectal Cancer

Keywords

trifluridine/tipiracil; combination chemotherapy; metastatic colorectal cancer; irinotecan; oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Disease control rate (DCR)

  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 Outcomes (3)

• Progression-free survival (PFS)

  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)

  The evaluation period is up to 48 months from the date of ICF is signed to the date of death.

• Safety profile

  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.

Study Arms (1)

trifluridine / tipiracil + Chemotherapy

EXPERIMENTAL

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

Interventions

Trifluridine/tipiracil DRUG

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.

Also known as: (choose one combination) : oxalipatin or irinotecan

trifluridine / tipiracil + Chemotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the metastatic colorectal cancer;
• Previously treated with fluorouracil-, oxaliplatin-, and irinotecan-based chemotherapy, and anti-vascular endothelial growth factor (anti-VEGF) biological therapy;
• The RAS wild-type patients need to receive anti-EGFR therapy;
• 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);
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2;
• 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;
• Patients received either oxaliplatin or irinotecan.

You may not qualify if:

• Patients previously received Lonsurf® (Trifluridine／Tipiracil) or regorafenib;
• With active central nervous system (CNS) metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth);
• With clinically significant gastrointestinal hemorrhage;
• 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;
• 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;
• Active infection.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang-Gung Memorial Hospital, Linkou

Linkou District, Taiwan

RECRUITING

Related Publications (6)

• Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.

  PMID: 25970050 BACKGROUND

• Temmink OH, Hoebe EK, van der Born K, Ackland SP, Fukushima M, Peters GJ. Mechanism of trifluorothymidine potentiation of oxaliplatin-induced cytotoxicity to colorectal cancer cells. Br J Cancer. 2007 Jan 29;96(2):231-40. doi: 10.1038/sj.bjc.6603549.

  PMID: 17242697 BACKGROUND

• Temmink OH, Hoebe EK, Fukushima M, Peters GJ. Irinotecan-induced cytotoxicity to colon cancer cells in vitro is stimulated by pre-incubation with trifluorothymidine. Eur J Cancer. 2007 Jan;43(1):175-83. doi: 10.1016/j.ejca.2006.08.022. Epub 2006 Oct 16.

  PMID: 17049227 BACKGROUND

• Argiles G, Andre T, Hollebecque A, Calvo A, Dahan L, Cervantes A, Leger C, Amellal N, Fougeray R, Tabernero J. Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer. Eur J Cancer. 2019 May;112:12-19. doi: 10.1016/j.ejca.2019.01.101. Epub 2019 Mar 16.

  PMID: 30889492 BACKGROUND

• Doi T, Yoshino T, Fuse N, Boku N, Yamazaki K, Koizumi W, Shimada K, Takinishi Y, Ohtsu A. Phase I study of TAS-102 and irinotecan combination therapy in Japanese patients with advanced colorectal cancer. Invest New Drugs. 2015 Oct;33(5):1068-77. doi: 10.1007/s10637-015-0271-1. Epub 2015 Jul 12.

  PMID: 26163340 BACKGROUND

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 RESULT

Related Links

• Ministry of Health and Welfare, National Health Service. Cancer Registration Report

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

trifluridine tipiracil drug combination; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Hung-Chih Hsu

  Chang Gung Memorial Hospital, Linkou, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Chih Hsu

CONTACT

+886 33281200; dannyhsuyoyo@gmail.com

Ya-Wen Ho

CONTACT

+886 975872851; vengi0512@tty.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 10, 2024
• Study Start: March 19, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-03

Locations

TW (1)