Trial Information
Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Shiying Yu, Master
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tongji Cancer Center
Authority:
China: Ethics Committee
Study ID:
TJCC-GC001
NCT ID:
NCT01197118
Start Date:
September 2010
Completion Date:
May 2011
Related Keywords:
- Gastric Cancer
- gastric cancer
- sequence chemoradiotherapy
- OLF regimen
- survival rate
- Stomach Neoplasms