A Phase II Trial of Intensity-Modulated Radiotherapy Combined With S-1 Based Chemotherapy in Completely Resected Gastric Cancer
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Overall survival
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
S-1 based chemoradiotherapy
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.
Intervention: intensity-modulated radiotherapy (Radiation)
S-1 based chemoradiotherapy
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.
Intervention: S-1 (Drug)
Outcomes
Primary Outcomes
Overall survival
Time Frame: 3 years
Locoregional recurrence free survival
Time Frame: 3 years
Distant metastasis free survival
Time Frame: 3 years
Disease free survival
Time Frame: 3 years
Secondary Outcomes
- Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0(during treatment and within the first 30 days after completion of chemoradiotherapy)
Investigators
Wang Xin
Cancer Hospital
Chinese Academy of Medical Sciences