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

ABSTRACT: 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

DISEASE(S): Colorectal Cancer

PROVIDER: 2609649 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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 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 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

Data in support of administration of a soluble TNF inhibitor that reduces infarct volume after focal cerebral ischemia in mice

Project description:Background: Tumor necrosis factor, which exists both as a soluble (solTNF) and a transmembrane (tmTNF) protein, plays an important role in post-stroke inflammation. The objective of the present study was to test the effect of topical versus intracerebroventricular administration of XPro1595 (a solTNF inhibitor) and etanercept (a solTNF and tmTNF inhibitor) compared to saline on output measures such as infarct volume and post-stroke inflammation in mice. Methods: Adult male C57BL/6 mice were treated topically (2.5 mg/ml/1µl/hr for 3 consecutive days) or intracerebroventricularly (1.25 mg/kg/0.5 ml, once) with saline, XPro1595, or etanercept immediately after permanent middle cerebral artery occlusion (pMCAO). Mice were allowed to survive 1 or 3 days. Infarct volume, microglial and leukocyte profiles, and inflammatory markers were evaluated. Results: We found that topical, and not intracerebroventricular, administration of XPro1595 reduced infarct volume at both 1 day and 3 days after pMCAO. Etanercept showed no effect. We observed no changes in microglial or leukocyte populations. XPro1595 increased gene expression of P2ry12 at 1 day and Trem2 at 1 and 3 days, while decreasing Cx3cr1 expression at 1 and 3 days after pMCAO, suggesting a change in microglial activation towards a phagocytic phenotype. Conclusions: Our data demonstrate that topical administration of XPro1595 for three consecutive days decreases infarct volumes after ischemic stroke, while modifying microglial activation and the inflammatory response post-stroke. This suggests that inhibitors of solTNF hold great promise for future neuroprotective treatment in ischemic stroke.

2019-11-12 | PXD014440 | Pride

HiSCO 03 study

Project description:Interventions: Start protocol treatment within 8 weeks after surgery. If it was not possible to start within 8 weeks after surgery, state the reason on the treatment progress record sheet. Test treatment UFT is administered orally three times a day (about every 8 hours) avoiding one hour before and after meal, dividing equivalent amount of 300 to 600 mg of tegafur (300 mg/m 2/day). LV (Uzel tablet) is 75 mg/day divided three times a day, and it is orally administered simultaneously with UFT. This is administered for 28 consecutive days, followed by 7 days off. As this is one course, we will implement 5 courses (25W). Primary outcome(s): Feasibility An aborted case because of the reason of 1) or 2) is regarded as an event. An aborted case because of the reason of 3) to 5) is regarded as a censored case and calculated the cumulative completion rate by the Kaplan-Meier method or the like. For the calculation of the confidence interval of the cumulative completion rate at 25 weeks after UFT / LV administration, Greenwood’s equation is used. 1) Canceling due to side effects. 2) Canceling due to patient refusal. 3) Canceling due to complications after curative treatment. 4) Canceling due to recurrence or death. 5) Canceling cases due to patient transfers. Study Design: single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose

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| 2616118 | 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

Targeted pharmacological therapy restores β-cell function for diabetes remission

Project description:This dataset consists of single-cell RNA-seq (10X) data from disperesed pancreatic islets of healthy and STZ induced diabetic mice. STZ (Sigma) was injected intraperitoneally in 8-week old male C57BLJ/6 mice at 50 mg/kg for five consecutive days. Islets were isolated from healthy mice and STZ diabetic mice after 100 days of either vehicle or drug treatment.

2020-02-20 | GSE128565 | GEO

RNA-SEQ profiling of dopaminergic neurons from the mid-brain of mice that received intraperitoneal injections of MPTP

Project description:RNA-SEQ of dopaminergic neurons from the mid-brain of mice that received one daily intraperitoneal injection of MPTP-HCl (30 mg/kg free base per day) or saline for five consecutive days. Samples were taken 4 days.

2015-07-27 | GSE54795 | GEO

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