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

ABSTRACT: Interventions: investigational material(s) Generic name etc : S-1(tegafur + gimeracil + oteracil potassium)/LV/L-OHP/Bevacizumab INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium LV:folic acid OHP:oxaliplatin Bevacizumab:bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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. Primary outcome(s): Response rate(RR) RECIST Study Design: Randomized, open-label, comparative study.

DISEASE(S): Untreated Metastatic Colorectal Cancer

PROVIDER: 99902 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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.

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

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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

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

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