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A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer
Conditions
Stomach Neoplasms - Chemoradiotherapy, Adjuvant - Radiotherapy, Intensity-Modulated
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: intensity-modulated radiotherapy
Type: Radiation
Name: S-1
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China
Status: Recruiting
Contact: Xin Wang, MD - +8613311583220 - beryl_wx2000@163.com
Start Date
January 2014
Completion Date
December 2016
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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