Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer
NCT ID: NCT01197118
Last Updated: 2010-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2010-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2
chemotherapy alone following radical resection
chemotherapy alone following radical resection
Postoperative chemotherapy regimen: The OLF regimen was administrated: Oxaliplatin, 130 mg/m2/day on day1, i.v. 2 h; fluorouracil, 425 mg/m2/day on day1\~5, i.v.; leucovorin, 200 mg/m2/day on day 1\~5, i.v.; every 21 days repeated, for 6 cycles.
1
sequence chemoradiotherapy following radical resection
sequence chemoradiotherapy
Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 15MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.
Postoperative chemotherapy regimen: see arm 2
Interventions
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sequence chemoradiotherapy
Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 15MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.
Postoperative chemotherapy regimen: see arm 2
chemotherapy alone following radical resection
Postoperative chemotherapy regimen: The OLF regimen was administrated: Oxaliplatin, 130 mg/m2/day on day1, i.v. 2 h; fluorouracil, 425 mg/m2/day on day1\~5, i.v.; leucovorin, 200 mg/m2/day on day 1\~5, i.v.; every 21 days repeated, for 6 cycles.
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Tongji Cancer Center
Principal Investigators
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Shiying Yu, Master
Role: PRINCIPAL_INVESTIGATOR
Tongji Cancer Center
Locations
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Tongji Cancer Center,Tongji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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TJCC-GC001
Identifier Type: -
Identifier Source: org_study_id