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

Phase 1
18 Years
75 Years
Open (Enrolling)
Gastrointestinal Neoplasms, Gastric Cancer

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Trial Information

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.

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,CNS,no peritoneal transplantation

- No prior abdominal or pelvic radiotherapy.

- 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 3,000G/L

- Platelets: greater than or equal to 100,000/mcL

- 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

- 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

- History of prior radiation to the abdomen

- Pregnant or lactating females

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

up to 9 weeks

Safety Issue:


Principal Investigator

Jing Jin, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology,Cancer Hospital and Institute,CAMS


China: Ethics Committee

Study ID:




Start Date:

November 2010

Completion Date:

September 2013

Related Keywords:

  • Gastrointestinal Neoplasms
  • Gastric Cancer
  • Combined Modality
  • Gastric Cancer
  • Radiation Therapy
  • S-1
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Stomach Neoplasms