drugset / Trial / NCT01197118

Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer

NCT01197118 ↗

Phase 2 Unknown 40 enrolled Huazhong University of Science and Technology
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-09
Primary completion
2010-12
Completion
2011-05

Publications

  • Background Xiang-Lin Yuan, Qiang Fu ,Shi-Ying Yu .Postoperative sequence chemoradiotherapy for advanced gastric cancer:an analysis of 36 cases.World Chinese Journal of Digestology,2007(36):3856-3859.

Drugs

EvaluationDrugModalityDoseRoute
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject fluorouracil Small molecule 425 mg/m2 Intravenous

Indications