Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Neoplasm Metastasis

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Trifluridine

Antimetabolites

Antiviral Agents

Trifluridine and tipiracil will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.

trifluridine and tipiracil

Placebo will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.

Placebo

Takayuki Yoshino, MD, PhD

Toshiki Masuishi, Dr.

Yoshiaki Nakamura, Dr.

Tomohiro Nishina, Dr.

Takanori Goi, Dr.

Keiji Hirata, Dr.

Ichiro Takemasa, Dr.

Yoshito Komatsu, Dr.

Masahito Kotaka, Dr.

Toshikazu Moriwaki, Dr.

Keishi Nakamura, Dr.

Akihito Tsuji, Dr.

Yu Sunakawa, Dr.

Jun Watanabe, Dr.

Manabu Shiozawa, Dr.

Masanobu Takahashi, Dr.

Masato Nakamura, Dr.

Mitsuhisa Takatsuki, Dr.

Shogen Boku, Dr.

Mamoru Uemura, Dr.

Masahiro Gotou, Dr.

Akiyoshi Kanazawa, Dr.

Kazushige Kawai, Dr.

Atsuo Takashima, Dr.

Kensei Yamaguchi, Dr.

Eiji Sunami

Tadamichi Denda, Dr.

Masaru Morita, Dr.

Eiji Oki, Dr.

Nobuhisa Matsuhashi, Dr.

Hideki Ohdan, Dr.

Yuji Miyamoto, Dr.

Yoshiaki Kuriu, Dr.

Dai Manaka, Dr.

Fuminori Teraishi, Dr.

Takeshi Kato, Dr.

Hiroki Hara, Dr.

Kentaro Yamazaki, Dr.

Shinya Kajiura, Dr.

Kun-Huei Yeh, Dr.

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.

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

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

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.

This rate is defined as the proportion of subjects who became negative for ctDNA at the test immediately after completion of study treatment.

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.

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.

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.

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

Alpha-A, Inc.

National Cancer Center Hospital East

MD., PhD Head of Department of Gastroenterology and Gastrointestinal Oncology

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

Sotorasib

Panitumumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will be administered trifluridine and tipiracil, or regorafenib

Panitumumab will be administered as intravenous (IV) infusion

Trifluridine and Tipiracil will be administered orally

Trifluridine and Tipiracil

Regorafenib

The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

A TEAE is any untoward medical occurrence in a clinical study participant following first dose of treatment irrespective of a causal relationship with the study treatment. Any clinically significant changes in vital signs and clinical laboratory tests following first dose will be recorded as TEAEs.

Item 3 of the BFI records a participants' fatigue on a scale from 0 to 10. Higher scores indicate a higher severity of fatigue. An increase in score from baseline indicates a worsening of fatigue. A decrease in score from baseline indicates an improvement in fatigue.

Item 3 of the BPI records a participants' pain on a scale from 1 to 10, where pain is mild (score of 1 to 4), moderate (score of 5 to 6), or severe (score of 7 to 10). An increase in score from baseline indicates a worsening of pain. A decrease in score from baseline indicates a lessening of pain.

The physical function domain of the EORTC QLQ-C30 assesses a participants' quality of life regarding their physical function on a scale from 1 to 4, with higher scores indicating a worse outcome. An increase in score from baseline indicates a worsening of physical functioning. A decrease in score from baseline indicates an improvement in physical functioning.

Questions 29 and 30 of the EORTC QLQ-C30 assess a participants' global health status on a scale from 1 to 7, with higher scores indicating a better outcome. An increase in score from baseline indicates an improvement in global health status. A decrease in score from baseline indicates a worsening in global health status.

The BFI is a questionnaire that includes 3 items to assess fatigue severity and 5 items to assess interference due to fatigue, with each item reported on a numeric rating scale from 0 to 10. Higher scores indicate a higher severity of fatigue. An increase in score from baseline indicates a worsening of fatigue. A decrease in score from baseline indicates an improvement in fatigue.

The BPI is a 9-item questionnaire which includes 2 body diagrams, four items to assess pain severity, four items to assess pain interference and one question about percentage of pain relief by analgesics. The level of pain and pain interference assessed can be divided into categories based on score of mild (1 to 4), moderate (5 to 6), and severe (7 to 10). An increase in score from baseline indicates a worsening of pain. A decrease in score from baseline indicates a lessening of pain.

The EORTC QLQ-C30 is a self-reporting 30-item generic instrument which assesses 5 functional domains (physical, role, emotional, cognitive, social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and a global health status/quality of life (QOL) scale. Higher scores indicate a worse outcome. An increase in score from baseline indicates a worsening of outcome. A decrease in score from baseline indicates an improvement in outcome.

The EQ-5D-5L questionnaire is a 2-page, standardized instrument for use as a measure of health outcome. It is comprised of a 5-dimension health status measure and a visual analogue scale. The 5-dimension health status measure evaluates: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

The GP5 from the FACT-G is a single item included in the Physical Well-Being subscale of the FACT-G. Responses to the item: "I am bothered by side effects of treatment" are rated on a 5-point Likert scale from "not at all" to "very much".

The PGIC scale consists of one item which measures the participants' perception of change in their condition relative to the beginning of the study. Responses are rated on a 7-item response scale ranging from very much improved to very much worse.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection	NCT04457297	Colorectal Neop... Trifluridine an... Circulating Tum...	trifluridine an... Placebo	20 Years -	National Cancer Center Hospital East
Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation	NCT05198934	Colorectal Canc...	Sotorasib Panitumumab Trifluridine an... Regorafenib	18 Years - 100 Years	Amgen
Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation	NCT05198934	Colorectal Canc...	Sotorasib Panitumumab Trifluridine an... Regorafenib	18 Years - 100 Years	Amgen
Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection	NCT04457297	Colorectal Neop... Trifluridine an... Circulating Tum...	trifluridine an... Placebo	20 Years -	National Cancer Center Hospital East

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