Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer

Huazhong University of Science and Technology1 site in 1 country40 target enrollmentSeptember 2010

ConditionsGastric Cancer

Interventionschemotherapy alone following radical resection sequence chemoradiotherapy

Drugschemotherapy alone following radical resection

Overview

Phase: Phase 2
Intervention: chemotherapy alone following radical resection
Conditions: Gastric Cancer
Sponsor: Huazhong University of Science and Technology
Enrollment: 40
Locations: 1
Primary Endpoint: overall survival
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

May 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

•Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction.
•Age of 18 to 75, Karnofsky score higher than
•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.