Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer

Study Overview
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Brief Summary
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Gastric cancer is one of the most prevalent malignancies in China; the survival rate remains poor despite potentially curative resections. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, even after a complete resection with negative margins, many patients will experience recurrence. In recent years, the radiation therapy in the carcinoma of the stomach represents a new issue that should be addressed accompanying the development of radial physics and radial biology, the clinical application of computed tomographic (CT) simulation and digital reconstitution technique, especially the application of 3-dimensional conformal and intensity modulated radiation therapy. Radiation therapy plus concurrent chemotherapy has been demonstrated to cause a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/SWOG 9008. So the investigators designed the trial to see whether a postoperative sequence chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve survival for advanced gastric cancer.

Official Title
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Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Radiation: sequence chemoradiotherapy
* Drug: chemotherapy alone following radical resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction. Age of 18 to 75, Karnofsky score higher than 70. Postoperative histologically conformed metastasis in perigastric lymph nodes and/or tumor invasion to muscularis propria or subserosa, with or without positive incisal margin. No severe functional damage of major organ, normal blood cell, normal liver and kidney function. No clinical findings of distant metastasis. Predictive survival time longer than 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>chemotherapy alone following radical resection | Drug: chemotherapy alone following radical resection<br>* Postoperative chemotherapy regimen: The OLF regimen was administrated: Oxaliplatin, 130 mg/m2/day on day1, i.v. 2 h; fluorouracil, 425 mg/m2/day on day1 5, i.v.; leucovorin, 200 mg/m2/day on day 1 5, i.v.; every 21 days repeated, for 6 cycles.<br>|
| Experimental: 1<br>sequence chemoradiotherapy following radical resection | Radiation: sequence chemoradiotherapy<br>* Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 15MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered. Postoperative chemotherapy regimen: see arm 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, sequence chemoradiotherapy, OLF regimen, survival rate