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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 1

Conditions: Gastric Cancer; Gastrointestinal Neoplasms

Treatments: Drug: S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT01291407

CH-GI-012

Details and patient eligibility

About

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.

Full description

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 Common Toxicity Criteria for Adverse Effects (CTCAE)3.0.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

S-1,peroral BID,capsule

Experimental group

Treatment:

Drug: S-1

Drug: S-1

Drug: S-1

Drug: S-1

Drug: S-1

Drug: S-1