Stomach Neoplasms Clinical Trial
Official title:
A Phase II Trial of Intensity-Modulated Radiotherapy Combined With S-1 Based Chemotherapy in Completely Resected Gastric Cancer
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.
Status | Unknown status |
Enrollment | 60 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Comparison of dosimetric differences between radiation techniques | To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning. | 1 year | |
Primary | Disease free survival | 3 years | ||
Primary | Locoregional recurrence free survival | 3 years | ||
Primary | Overall survival | 3 years | ||
Primary | Distant metastasis free survival | 3 years | ||
Secondary | Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0 | during treatment and within the first 30 days after completion of chemoradiotherapy |
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