Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer

Interventions: investigational material(s) Generic name etc : Irinotecan hydrochloride | Tegafur/Gimeracil/ Oteracil Potassium | Fluorouracil | Levofolinate Calcium INN of investigational material : Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Irinotecan hydrochloride : injection, Fluorouracil : injection, Levofolinate Calcium : injection, Tegafur/Gimeracil/ Oteracil Potassium capsule : oral Primary outcome(s): Progression free survival Study Design: Open label, multicenter phase 2 / 3 study