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Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, sequence chemoradiotherapy, OLF regimen, survival rate
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: sequence chemoradiotherapy
Type: Radiation
Name: chemotherapy alone following radical resection
Type: Drug
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
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.
Location
Tongji Cancer Center,Tongji Hospital
Wuhan, Hubei, China
Status: Not yet recruiting
Contact: Qiang Fu, Master - 86-27-83663342 - yunr777@yahoo.com.cn
Start Date
September 2010
Completion Date
May 2011
Sponsors
Huazhong University of Science and Technology
Source
Huazhong University of Science and Technology
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page