A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC).
Ontology highlight
ABSTRACT:
DISEASE(S): Bowel Cancer
PROVIDER: 97740 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Intervention name : UFT(tegafur + uracil)
INN of the intervention : UFT:tegafur, uracil
Dosage And administration of the intervention : oral uracil-tegafur 400 mg square meter for one year
Primary outcome(s): Efficacy and safety
Study Design: Randomized, comparative study
| 2609887 | 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
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 : 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 : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks
Generic name etc : L-OHP (Oxaliplatin)
INN of investigational material : oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks
Generic name etc : BV (Bevacizumab)
INN of investigational material : bevacizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks
control material(s)
Generic name etc : 5-FU (Fluorouracil)
INN of investigational material : fluorouracil
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks.
Generic name etc : l-LV (Levofolinate calcium)
INN of investigational material : folic acid
Therapeutic category code : 392 Antidotes
Dosage and Administration for Investigational material : 200 mg IV on day 1. Repeat cycles every 2 weeks.
Generic name etc : L-OHP (Oxaliplatin)
INN of investigational material : oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks.
Generic name etc : BV (Bevacizumab)
INN of investigational material : bevacizumab
Therapeutic category code : 429 Other antitumor agents
Dosage
Primary outcome(s): Progression free survival(PFS)
Study Design: Randomized, open-label, comparative study
| 97778 | 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 : TAS-102
INN of investigational material :
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
control material(s)
Generic name etc : Placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Primary outcome(s): Correlation between the relative factor and disease control rate, overall survival, or progression-free survival
RECIST (ver.1.1)
Study Design: Multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study
| 100784 | ecrin-mdr-crc
Project description:Intervention name : TS-1 (tegafur + gimeracil + oteracil potassium) L-OHP (Oxaliplatin)
INN of the intervention : TS-1: tegafur, gimeracil, oteracil potassium , oxaliplatin
Dosage And administration of the intervention : 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 intervention name : UFT(tegafur + uracil) LV (Folic acid)
INN of the control intervention : UFT: tegafur, uracil LV:folic acid
Dosage And administration of the control intervention : 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
| 2610281 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : Oxaliplatin | Tegafur-Gimeracil-Oteracil potassium capsule
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Oxaliptatin:Infusion, Tegafur-Gimeracil-Oteracil potassium capsule:Oral
Primary outcome(s): To determine RD,calculate response rate at the RD
Study Design: Open-label,multicenter trial
| 99273 | ecrin-mdr-crc