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A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).

ABSTRACT: Intervention name : S-1 (tegafur + gimeracil + oteracil potassium) INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium Dosage And administration of the intervention : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks Intervention name : L-OHP (Oxaliplatin) INN of the intervention : oxaliplatin Dosage And administration of the intervention : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks Intervention name : BV (Bevacizumab) INN of the intervention : bevacizumab Dosage And administration of the intervention : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks Control intervention name : 5-FU (Fluorouracil) INN of the control intervention : fluorouracil Dosage And administration of the control intervention : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks. Control intervention name : l-LV (Levofolinate calcium) INN of the control intervention : folic acid Dosage And administration of the control intervention : 200 mg IV on day 1. Repeat cycles every 2 weeks. Control intervention name : L-OHP (Oxaliplatin) INN of the control intervention : oxaliplatin Dosage And administration of the control intervention : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks. Control intervention name : BV (Bevacizumab) INN of the control intervention : bevacizumab Dosage And administration of the control intervention : 5 mg/kg IV on day 1. Repeat cycles every 2 weeks. Primary outcome(s): Progression free survival(PFS) Study Design: Randomized, open-label, comparative study

DISEASE(S): Untreated Metastatic Colorectal Cancer

PROVIDER: 2610116 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).

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

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

Phase 2 study of DS-8201a in subjects with colorectal cancer [DESTINY-CRC01]

Project description:Intervention name : DS-8201a INN of the intervention : trastuzumab deruxtecan Dosage And administration of the intervention : IV solution (Once every 3 weeks, 6.4 mg/kg) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): efficacy The objective response rate RECIST Version 1.1 Study Design: multi center, open-label, 3-cohort study

| 2658293 | ecrin-mdr-crc

METBEIGE Study

Project description:Intervention name : Cabozantinib Malate INN of the intervention : Cabozantinib Dosage And administration of the intervention : Cabozantinib: 40 mg or 60 mg, once daily at bedtime, oral, in a 28 day-course. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety, efficacy - Proportion of subjects with DLT (phase 1 part) - Confirmed ORR by investigators’ assessment in patients who received study treatment as 3rd line or later (phase 2 part) Study Design: An open-label, single arm phase I study and an open-label, randomized controlled multicenter phase II study

| 2611903 | ecrin-mdr-crc

A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer

Project description:Intervention name : OCV-C02 INN of the intervention : - Dosage And administration of the intervention : Once-weekly subcutaneous injection (0.3, 1 3 and 6 mg/body) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety Dose Limiting Toxicity (DLT) Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0 Study Design: multicenter, open, non-comparative study

| 2657927 | ecrin-mdr-crc

A phase I study of TAS-102 and irinotecan

Project description:Intervention name : TAS-102 Dosage And administration of the intervention : 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 intervention name : irinotecan INN of the control intervention : irinotecan Dosage And administration of the control intervention : 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

| 2610898 | ecrin-mdr-crc

DS-Screen

Project description:Intervention name : - INN of the intervention : - Dosage And administration of the intervention : - Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): exploratory FGFR2 and HER2 protein expression IHC Study Design: Observational study

| 2611525 | 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

Phase 1 study of CS-7017 in combination with FOLFIRI

Project description:Intervention name : CS-7017 INN of the intervention : efatutazone Dosage And administration of the intervention : CS-7017(0.25-0.50 mg) administered orally twice a day Control intervention name : null Primary outcome(s): Safety and Pharmacokinetics -To evaluate the safety profile according to CTCAE -To evaluate the pharmacokinetics according to the protocol Study Design: Open Label Phase 1 Study

| 2610363 | ecrin-mdr-crc

ONO-4538/CA2099X8 Phase 2/3 Study(ONO-4538-72/CA2099X8)

Project description:Intervention name : ONO-4538/BMS-936558 INN of the intervention : Nivolumab Dosage And administration of the intervention : Intravenous administration Control intervention name : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab INN of the control intervention : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab Dosage And administration of the control intervention : Intravenous administration Primary outcome(s): efficacy PFS Study Design: Randomized, open-label

| 2658327 | ecrin-mdr-crc

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