A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Radiotherapy, Intensity-Modulated; Chemoradiotherapy, Adjuvant; Stomach Neoplasms

Treatments: Radiation: intensity-modulated radiotherapy; Drug: S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02296658

NCC2013RE-088

Details and patient eligibility

About

The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection

• 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

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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60 participants in 1 patient group

S-1 based chemoradiotherapy

Experimental group

Description:

S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.

Treatment:

Radiation: intensity-modulated radiotherapy

Drug: S-1