A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with radiation therapy for locally advanced or recurrent gastric cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences

Criteria

Inclusion Criteria:

• Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients undergoing R0, R1, R2 resection, or with unresectable or locoregional recurrent disease

• Any prior chemotherapy is allowed in this protocol.

• No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation

• No prior abdominal or pelvic radiotherapy.

• Karnofsky performance status(KPS)≥ 70,predictive life span no less than 6 months

• Patients must have normal organ and marrow function as defined below:

• Leukocytes greater than or equal to 3,000 G/L

• Platelets: greater than or equal to 100,000/mm3

• Hemoglobin:greater than or equal to 10g/L

• Total bilirubin: within normal institutional limits

• AST/ALT: less than or equal to 1.5 times the upper limit

• Creatinine within normal upper limits

• Informed consent

• Without any serious complications,such as hypertension,coronary artery disease,psychiatric history.

Exclusion Criteria:

• Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer

• With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation

• History of allergic reactions attributed to similar chemical or biologic complex to S-1

• Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness

• History of myocardial infarction within the past 6 months or history of ventricular arrhythmia

• History of prior radiation to the abdomen

• Pregnant or lactating females