Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 97953 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
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
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 After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days.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 After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days.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
Project description:Interventions: investigational material(s)
Generic name etc : trifluridine/tipiracil
INN of investigational material : trifluridine/tipiracil
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 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.
Generic name etc : bevacizumab
INN of investigational material : bevacizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15.
control material(s)
Generic name etc : fluorouracil
INN of investigational material : fluorouracil
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : [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.
Generic name etc : TS-1(tegafur + gimeracil + oteracil potassium)
INN of investigational material : TS-1(tegafur + gimeracil + oteracil potassium)
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : [Treatment with TS-1+ irinotecan +bevacizumab (3-
Primary outcome(s): efficacy
Overall survival
Study Design: Randomized, open-label, comparative study
| 98099 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : TAS-102
INN of investigational material :
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : TAS-102 70 mg/m2 was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure.
control material(s)
Generic name etc : Placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Placebo was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure.
Primary outcome(s): Overall survival
To evaluate the overall survivals of TAS-102 versus placebo in patients with chemotherapy-refractory metastatic colorectal cancer
Study Design: Randomized, double-blind, placebo-controlled, parallel-group comparative study
| 99901 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : TAS-102
INN of investigational material :
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period).
control material(s)
Generic name etc : irinotecan
INN of investigational material : irinotecan
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for Investigational material : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15.
Primary outcome(s): Safety
CTCAE (ver.3.0)
Study Design: Open-label, multi-center, phase I study
| 100929 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : TSU-68, S-1, Oxaliplatin
INN of investigational material : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Treatment is repeated every 21 days as follows: S-1 is orally administered at 35 mg/m2 twice a day after meals on day 1-14 followed by 7 days rest. Oxaliplatin is given as an intravenous infusion of 130 mg/m2 on day 1. TSU-68 is orally administered at 200 mg or 400 mg twice a day after meals on day 1 to 21.
Primary outcome(s): Safety (dose limiting toxicity)
CTCAE (ver. 3.0)
Study Design: Open-label, phase I study
| 100333 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : TSU-68, S-1, Oxaliplatin
INN of investigational material : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium, oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Treatment is repeated every 21 days as follows: S-1 is orally administered at 35 mg/m2 twice a day after meals on day 1-14 followed by 7 days rest. Oxaliplatin is given as an intravenous infusion of 130 mg/m2 on day 1. Additionally for the patients of group A, TSU-68 is orally administered at 200 mg twice a day after meals on day 1 to 21.
control material(s)
Generic name etc : S-1, Oxaliplatin
INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Treatment is repeated every 21 days as follows: S-1 is orally administered at 35 mg/m2 twice a day after meals on day 1-14 followed by 7 days rest. Oxaliplatin is given as an intravenous infusion of 130 mg/m2 on day 1.
Primary outcome(s): Progression free survival
RECIST (ver. 1.1)
Study Design: Open-label, multicenter, randomized phase II study
| 100336 | ecrin-mdr-crc
Project description:Interventions: 1 cycle is 28days.
Lonsurf(25mg/m2)is administered orally twice daily in 1-5days and 8-12 days.
Irinotecan(100mg/m2) and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15.
Primary outcome(s): Recommended dose:RD
Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
| 2615622 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium)
INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : S-1 40-60 mg x 2/day was administered orally for one week followed by one week rest.
Generic name etc : LV (Levofolinate calcium)
INN of investigational material : folic acid
Therapeutic category code : 392 Antidotes
Dosage and Administration for Investigational material : LV 25 mg x 2/day was administered orally for one week along with S-1 followed by one week rest.
Primary outcome(s): Efficacy, Safety
Study Design: Open-label, Multi-center Study
| 99793 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : TS-1 (tegafur + gimeracil + oteracil potassium) L-OHP (Oxaliplatin)
INN of investigational material : TS-1: tegafur, gimeracil, oteracil potassium , oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : S-1 will be given twice daily in an oral dose of 80 to 120 mg according to body-surface area (after breakfast and dinner), from after dinner on day 1 to after breakfast on day 15, followed by a 7-day rest. L-OHP will be given in a dose of 100 mg/m2 as a 2-hour continuous intravenous infusion. Three weeks is defined as 1 course, and 8 courses (24 weeks) will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment.
control material(s)
Generic name etc : UFT(tegafur + uracil) LV (Folic acid)
INN of investigational material : UFT: tegafur, uracil LV:folic acid
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : UFT will be given orally in a dose of 300 to 600 mg of tegafur per day according to body-surface area (standard dose: 300 mg/m2/day) in 3 divided doses (at approximately 8-hour intervals, i.e., on awakening [7 a.m.], at 3 p.m., and at bedtime [11 p.m.]), avoiding 1 hour before and after meals. LV will be given in an oral dose of 75 mg/day 3 times daily at the same times as UFT. UFT plus LV is given for 28 consecutive days, followed by a 7-day rest. This is defined as 1 course of treatment. A total of 5 courses will be administered. Thereafter, patients will be followed up until confirmation of recurrence, without receiving any further treatment.
Primary outcome(s): efficacy
Disease-free survival (DFS)
Study Design: Randomized, open-label, comparative study
| 97801 | ecrin-mdr-crc