A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
This is a Phase I trial of S-1 given in treatment days with an oral dose from 30mg/m2/d to
80mg/m2/d, concurrently with radiation in patients with locally advanced or locally
recurrent gastric cancer. Patients will be treated with external beam radiation therapy in a
standard manner. S-1 will be administered for 6 dose levels,30/40/50/60/70/80mg/m2/d.
Patients will be assessed for acute toxicities according to CTCAE 3.0.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define dose limited toxicities(DLT) of S-1, peroral BID, in treatment days concurrently with radiation therapy (RT) in locally advanced or recurrent gastric cancer.
Dose limited toxicities defined as below: leucopenia ≥4 neutropenia ≥ 4, anemia ≥ 3, thrombocytopenia ≥ 3, ALT/AST ≥ 3, ALP ≥ 3, rGT ≥ 3, TBIL ≥ 3, BUN/Cr ≥ 2,non-gradular cell decreased fever ≥ 2, nausea/vomiting ≥ 2, fatigue ≥ 3, weight loss ≥ 3, diarrhea ≥ 3, abdominal pain ≥ 3, dysphagia ≥ 3, hand-foot symdrome ≥ 2, neurotoxicity ≥ 2.
up to 9 weeks
Jing Jin, MD,PhD
Department of Radiation Oncology,Cancer Hospital and Institute,CAMS
China: Ethics Committee