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Phase III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer

ABSTRACT: Interventions: A: UFT/LV group 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. B: SOX group 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. Primary outcome(s): Disease-free survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

DISEASE(S): Curability A, Stageiiib Colorectal Cancer

PROVIDER: 2614159 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer (ACTS-CC 02)

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

Phase III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer (ACTS-CC 02)

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

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

TRUSTY

Project description:Interventions: <Fluoropyrimidine+irinotecan+bevacizumab treatment arm> Prior to enrollment, investigator or subinvestigator select one of the following scheduled regimens for each patient. 1.FOLFIRI+bevacizumab therapy Bevacizumab 5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1. After that, irinotecan 150mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1. At the same time, levofolinate 200mg/ m^2 is given as an infusion of the course of 2 hours on Day1. After that, fluorouracil 400 mg/ m^2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/ m^2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. 2. S-1+irinotecan+bevacizumab therapy with a 3-week cycle Bevacizumab 7.5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1. After that, irinotecan 150 mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1. S-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 treatment was repeated until the criteria for withdrawal of the study treatment were met. 3. S-1+irinotecan+bevacizumab therapy with a 4-week cycle Bevacizumab 5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1 and Day 15. After that, irinotecan 100 mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1 and Day 15. S-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-sur Primary outcome(s): Overall survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2613990 | ecrin-mdr-crc

A Randomized Trial of Adjuvant Chemotherapy with UFT / LV versus PSK / UFT / LV following curative resection for Stage II / III Colorectal Cancer

Project description:Interventions: Group A (standard therapy group:UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. Group B (trial therapy group: PSK/UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. And administration of every day PSK (3g/body) for 6 months. Group C (trial therapy group: PSK/UFT/LV 12M): Administration of 10 courses (12 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. And administration of every day PSK (3g/body) for 12 months. Primary outcome(s): 3 year desease free survival rate Study Design: Parallel Randomized

| 2620921 | 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: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

Transcriptomic profiling of S2/S3 proximal tubules in response to LPS treatment

Project description:To investigate the mechanisms of endotoxin-mediated kidney injury as well as renoprotective effects of endotoxin preconditioning, we performed manual microdissection of S2/S3 proximal tubules in mice as follows: 1) Non-preconditioned mice subjected to single-dose 5 mg/kg LPS (0111:B4) i.p. for 4 hrs. 2) Non-preconditioned mice subjected to single-dose 5 mg/kg LPS (0111:B4) for 24 hrs. 3) Preconditioned mice subjected to 0.25 mg/kg LPS followed 24 hour later by 5 mg/kg LPS for 4 hrs. 4) Preconditioned mice subjected to 0.25 mg/kg LPS followed 24 hour later by 5 mg/kg LPS for 24 hrs. 5) Control mice (untreated).

2018-10-06 | GSE120879 | GEO

A study on taking method of adjuvant Tegafur-Uracil and Leucovorin Calcium in patients with resected Colorectal Cancer (Three times-daily regimen Versus twice-daily regimen)

Project description:Interventions: A group(three taimes-daily) UFT was administered at a dose of 300 mg/m2/day, and LV was administered at a dose of 75 mg/day. The daily doses of both UFT and LV were divided into three doses administered 8 hours apart and taken together along with water. Repeat five 35-day cycles consisting of 28- day of oral chemotherapy administration and then a 7-day rest period. B group(twice-daily) UFT was administered at a dose of 300 mg/m2/d, and LV was administered at a dose of 50 mg/day. The daily doses of both UFT and LV were divided into twice doses and taken together along with water. Repeat five 35-day cycles consisting of 28- day of oral chemotherapy administration and then a 7-day rest period. Primary outcome(s): 3-year Disease-free survival Study Design: Parallel Randomized

| 2621031 | ecrin-mdr-crc

Randomized pilot study comparing safety of irinotecan+S-1(IRIS)+bevacizumab and mFOLFIRI+bevacizumab for metastatic colorectal cancer (T-CORE0702)

Project description:Interventions: FOLFIRI + bevacizumab consisted of bevacizumab 5mg/kg as a 90-minute infusion, then, l-LV 200 mg/m2 as a 2-hour infusion, and irinotecan 150 mg/m2 given as a 90-minute infusion, followed by bolus FU 400 mg/m2 and a 46-hour infusion FU 2,400 mg/m2, repeated every 2 weeks. IRIS + bevacizumab consisted of bevacizumab 7.5mg/kg as a 90-minute infusion, then, irinotecan 150 mg/m2 given as a 90-minute infusion, followed by oral S-1 (40 mg/m2) twice daily 14 days (day 3 to 16) followed by 5 days rest, repeated every 3 weeks. Primary outcome(s): safety Study Design: Parallel Randomized

| 2616274 | ecrin-mdr-crc

Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer

Project description:Interventions: Group A (standard therapy group): Administration of 5 courses (6 months) of a schedule (consecutive administration method) in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. Group B (trial therapy group): Administration of 15 courses (18 months) of a schedule (5 days on, 2 days off: Saturday and Sunday) in which one course consists of 5 weeks of UFT (300 mg/m2/day) and LV (75 mg/day) for 5 consecutive days followed by 2 days off. Primary outcome(s): disease-free survival Study Design: Parallel Randomized

| 2609649 | ecrin-mdr-crc

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