Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer

Phase 2

• Conditions: Gastric Cancer
• Interventions: Drug: chemotherapy alone following radical resection; Radiation: sequence chemoradiotherapy

• Registration Number: NCT01197118
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-23
• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted QC: 2010-09-08
• Last Update Submitted: 2010-09-08
• Study First Posted: 2010-09-09
• Last Update Posted: 2010-09-09
• Primary Completion: 2010-12
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	chemotherapy alone following radical resection	chemotherapy alone following radical resection
1	sequence chemoradiotherapy	sequence chemoradiotherapy following radical resection

Primary Outcome Measures

Name	Time	Method
overall survival	1 year

Trial Locations

Locations (1)

Tongji Cancer Center,Tongji Hospital; 🇨🇳 Wuhan, Hubei, China