Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer
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ClinicalTrials.gov Identifier: NCT01197118 |
Recruitment Status : Unknown
Verified September 2010 by Huazhong University of Science and Technology.
Recruitment status was: Not yet recruiting
First Posted : September 9, 2010
Last Update Posted : September 9, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Radiation: sequence chemoradiotherapy Drug: chemotherapy alone following radical resection | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer |
Study Start Date : | September 2010 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 2
chemotherapy alone following radical resection
|
Drug: 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. |
Experimental: 1
sequence chemoradiotherapy following radical resection
|
Radiation: 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 |
- overall survival [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction.
- Age of 18 to 75, Karnofsky score higher than 70.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197118
Contact: Qiang Fu, Master | 86-27-63089811 | yunr777@yahoo.com.cn |
China, Hubei | |
Tongji Cancer Center,Tongji Hospital | |
Wuhan, Hubei, China, 430030 | |
Contact: Qiang Fu, Master 86-27-83663342 yunr777@yahoo.com.cn | |
Contact: Shiying Yu, Master 86-27-83663342 syyu@tjh.tjmu.edu.cn | |
Principal Investigator: Shiying Yu, Master | |
Sub-Investigator: Qiang Fu, Master |
Principal Investigator: | Shiying Yu, Master | Tongji Cancer Center |
Responsible Party: | Shiying Yu / Chief, Tongji Cancer Center |
ClinicalTrials.gov Identifier: | NCT01197118 |
Other Study ID Numbers: |
TJCC-GC001 |
First Posted: | September 9, 2010 Key Record Dates |
Last Update Posted: | September 9, 2010 |
Last Verified: | September 2010 |
gastric cancer sequence chemoradiotherapy OLF regimen survival rate |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |