A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: S-1 based chemoradiotherapy S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner. |
Radiation: intensity-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.
Drug: S-1
S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.
|
Outcome Measures
Primary Outcome Measures
- Disease free survival [3 years]
- Locoregional recurrence free survival [3 years]
- Overall survival [3 years]
- Distant metastasis free survival [3 years]
Secondary Outcome Measures
- Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0 [during treatment and within the first 30 days after completion of chemoradiotherapy]
Other Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection
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Any prior chemotherapy is allowed in this protocol
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No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
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No prior abdominal or pelvic radiotherapy
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Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
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Patients must have normal organ and marrow function as defined below:
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Leukocytes greater than or equal to 3,000 G/L
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Platelets: greater than or equal to 100,000/mm3
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Hemoglobin:greater than or equal to 10g/L
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Total bilirubin: within normal institutional limits
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AST/ALT: less than or equal to 1.5 times the upper limit
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Creatinine within normal upper limits
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Informed consent
Exclusion Criteria:
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Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
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With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation
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History of allergic reactions attributed to similar chemical or biologic complex to S-1
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Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
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History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
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History of prior radiation to the abdomen
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Pregnant or lactating females
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Beijing | China | 100021 |
Sponsors and Collaborators
- Chinese Academy of Medical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCC2013RE-088