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

ABSTRACT: 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

DISEASE(S): Stage Iiib Colorectal Cancer

PROVIDER: 2610281 | 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: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 III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer

Project description: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

| 2614159 | ecrin-mdr-crc

Phase II Study of S-1 plus LV (1 week on and 1 week off) as First-line Treatment for Patients with metastatic colorectal cancer.

Project description:Intervention name : S-1 (tegafur + gimeracil + oteracil potassium) INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium Dosage And administration of the intervention : S-1 40-60 mg x 2/day was administered orally for one week followed by one week rest. Intervention name : LV (Levofolinate calcium) INN of the intervention : folic acid Dosage And administration of the intervention : 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

| 2610136 | 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

Clinical trial on the QOL of the Tegafur/Uracil plus Leucovolin(UFT/LV) to adjuvant chemotherapy for the Stage II, III colorectal cancer

Project description:Interventions: Tegafur/uracil with oral leucovorin(UFT/LV) UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive days followed by a 7 days rest. Primary outcome(s): Quality of Life Study Design: Single arm Non-randomized

| 2624363 | 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

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

Phase II Study of SOL and Bevacizumab Combination Therapy in patients with Untreated Metastatic Colorectal Cancer.

Project description:Intervention name : S-1(tegafur + gimeracil + oteracil potassium)/LV/L-OHP/Bevacizumab INN of the intervention : S-1:tegafur, gimeracil, oteracil potassium LV:folic acid OHP:oxaliplatin Bevacizumab:bevacizumab Dosage And administration of the intervention : S-1 40-60 mg bid day 1-day 7, LV 25 mg bid day 1-day 7, L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle, Bevacizumab 5 mg/kg iv. for 90 min on day 1 of each 2 weeks cycle. Control intervention name : null Primary outcome(s): Response rate(RR) RECIST Study Design: Randomized, open-label, comparative study.

| 2610204 | ecrin-mdr-crc

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

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC).

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

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