Chemoradiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Stomach Neoplasms
Conditions
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.
Interventions
RADIATIONintensity-modulated radiotherapy
A total irradiation dose of 45 Gy was delivered in daily 1.8-Gy fractions (5 days a week over 5 weeks) to all patients.
DRUGS-1
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | 3 years |
| Locoregional recurrence free survival | 3 years |
| Overall survival | 3 years |
| Distant metastasis free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0 | during treatment and within the first 30 days after completion of chemoradiotherapy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of dosimetric differences between radiation techniques | 1 year | To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning. |
Countries
China
Contacts
Primary ContactJing Jin, MD
Outcome results
None listed