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ALTAIR study

ABSTRACT: Intervention name : Lonsurf combination tablet T15/T20 INN of the intervention : trifluridine + tipiracil hydrochloride Dosage And administration of the intervention : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days. Primary outcome(s): efficacy Disease-Free Survival 1 (DFS1) The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, the first development of a secondary large intestine carcinoma lesion other than a relapse (an intramucosal cancer lesion will not be treated as an event) that is confirmed after the date of enrollment, and death from any cause. In principle, events will be assessed by the investigator. Study Design: 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.

DISEASE(S): Colorectal Cancer

PROVIDER: 2658591 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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ALTAIR study

Project description:Interventions: investigational material(s) Generic name etc : Lonsurf combination tablet T15/T20 INN of investigational material : trifluridine + tipiracil hydrochloride Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days. control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days. Primary outcome(s): efficacy Disease-Free Survival 1 (DFS1) The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, the first development of a secondary large intestine carcinoma lesion other than a relapse (an intramucosal cancer lesion will not be treated as an event) that is confirmed after the date of enrollment, and death from any cause. In principle, events will be assessed by the investigator. Study Design: 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.

| 102757 | ecrin-mdr-crc

JCOG2014: Randomized phase III study of bi-weekly trifluridine/tipiracil plus bevacizumab vs trifluridine/tipiracil alone for chemorefractory metastatic colorectal cancer

Project description:Interventions: A: FTD/TPI monotherapy FTD/TPI (35 mg/m2 given orally twice daily on days 1-5 and 8-12 in a 28-day cycle) B: Bi-weekly FTD/TPI+BEV combination Bi-weekly FTD/TPI (35 mg/m2 given orally twice daily on days 1-5 in a 14-day cycle) with BEV (5 mg/kg on day1, every 2 weeks) Primary outcome(s): Overall survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2614546 | ecrin-mdr-crc

E-BiTS study

Project description:Interventions: Patients will receive biweekly FTD/TPI (35mg twice daily on days 1-5, every 2 weeks) with BEV (5mg/kg on day 1, every 2weeks).Between second cycles and fourth cycles, the dose of FTD/TPI will be escalated if patients meet criteria of FTD/TPI dose escalation. Primary outcome(s): Disease control rate Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

| 78988 | ecrin-mdr-crc

Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)

Project description:Intervention name : trifluridine/tipiracil INN of the intervention : trifluridine/tipiracil Dosage And administration of the intervention : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met. Intervention name : bevacizumab INN of the intervention : bevacizumab Dosage And administration of the intervention : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15. Control intervention name : fluorouracil INN of the control intervention : fluorouracil Dosage And administration of the control intervention : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. Control intervention name : TS-1(tegafur + gimeracil + oteracil potassium) INN of the control intervention : TS-1(tegafur + gimeracil + oteracil potassium) Dosage And administration of the control intervention : [Treatment with TS-1+ irinotecan +bevacizumab (3-week cycles) ] TS-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatmen Primary outcome(s): efficacy Overall survival Study Design: Randomized, open-label, comparative study

| 2611617 | ecrin-mdr-crc

The Chromatin Remodeler Chromodomain Helicase DNA Binding Protein 2 Promotes Colorectal Cancer Progression

Project description:Integrative analysis of colorectal cancer (CRC) whole genomes and matched transcriptomes revealed that somatic promoter mutations are associated with increased Chromodomain helicase DNA-binding protein 2 (CHD2) levels. In both primary and metastatic CRC patients, elevated CHD2 levels are associated with worse prognosis and overall survival. We find that CHD2 increases promoter-transcription start site-chromatin accessibility and transcriptional upregulation of multiple oncogenes. In vitro, elevated CHD2 promoted CRC cell proliferation, migration and growth. In orthotopic xenografts, CHD2 promoted higher tumor burden and abdominal metastases, most prominently to the liver. FTD/TPI is an FDA approved chemotherapy for advanced chemo-refractory CRC. In orthotopic CRC models, FTD/TPI was highly effective in reducing metastases and prolonging survival for CHD2 high expressing CRCs. Thus, high CHD2 expression may be a potential CRC chemopredictive biomarker for FTD/TPI. Overall, these results provide new insights into the role of non-coding mutations and CHD2 levels to promote CRC growth and metastasis.

2021-02-12 | GSE146398 | GEO

Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20

Project description:Intervention name : Lonsurf combination tablet T15/T20 INN of the intervention : trifluridine + tipiracil hydrochloride Dosage And administration of the intervention : Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area (approximately 35 mg of Trifluridine/m2/dose). Lonsurf is administered twice daily, after breakfast and after the evening meal, for 5 consecutive days, followed by a 2-day rest. After repeating this twice, follows a 14-day rest. This is one cycle of the regimen and it shall be repeated. Study Design: Postmarketing surveillance

| 2611187 | ecrin-mdr-crc

Perioperative administration of probiotics-colorectal cancer-operated by laparoscopy.

Project description:Interventions: Group I (experimental): PROBIOTIKOS nº 2 (Brand Name), composed of a mixture of Lactobacillus rhamnosus (2 x 109 CFU/caps), Bifidobacterium breve (2 x 109 CFU/caps) and Lactobacillus casei (1x109 CFU/caps). Group II (control): Placebo compound by Maltodextrin 330 mg/caps. All two groups will receive 1 capsule of treatments or placebo orally twice a day with food breakfast/dinner) for three consecutive days before surgery (from day -3 to day -1 included). The day of surgery (day 0) the dose is 2 capsules in the early morning, offer it with a little amount of water. Treatments or placebo will be resumed postoperatively twice a day with food (breakfast/dinner) on day +2 until day +7 for a total of 10 days of treatment (20 doses). Primary outcome(s): • Postoperative diarrhea incidence, measuring time: day +8 and day +30 • Postoperative infectious complications incidence, measuring time: day +8 and day +30 • Quality of Live (FACT-C questionnaire), measuring time: day -4; day +8 and day +30 Study Design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Other

| 2571458 | ecrin-mdr-crc

Probiotic yogurt on chemotherapy-induced diarrhea

Project description:Intervention 1: Intervention group: Symptomatic treatment (Loperamide 4mg followed by 2 mg every 4 hours) with Probiotic yogurt (150 Grams) before breakfast and dinner twice a day for one week. Intervention 2: Control group: Symptomatic treatment Symptomatic treatment (Loperamide 4mg followed by 2 mg every 4 hours) with Regular yogurt (150 Grams) before breakfast and dinner twice a day for one week. Intervention 3: Control group: Symptomatic treatment Symptomatic treatment (Loperamide 4mg followed by 2 mg every 4 hours) with No intervention. Primary outcome(s): Diarrhea frequency. Timepoint: Daily for one week after the start of the Intervention. Method of measurement: Patient’s report.;Diarrhea intensity. Timepoint: Daily for one week after the start of the Intervention. Method of measurement: Patient’s report.;Stool consistency. Timepoint: Daily for one week after the start of the Intervention. Method of measurement: Observation. Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The study subjects were randomly allocated to yogurt + probiotic, yogurt, and control groups using Random Allocation Software (RAS) through random block sizes of 6 with an allocation ratio of 1:1. Random sequencing allocation was produced by the person who did not participate in the Sampling. The software produces sequences with 2 samples in each group. Containers were numbered from 1 to 90 according to the sequence generated.

| 2475794 | ecrin-mdr-crc

Prospective observational study investigating the impact of treatment sequence using regorafenib and FTD/TPI for metastatic colorectal cancer on overall survival

Project description:Primary outcome(s): Overall survival (OS) of sequential treatment with regorafenib-FTD/TPI

| 2655323 | ecrin-mdr-crc

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

Project 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.

| 2344525 | ecrin-mdr-crc

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