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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
Sponsor:
Information provided by:
Huazhong University of Science and Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Radiation: sequence chemoradiotherapy Drug: chemotherapy alone following radical resection Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. overall survival [ Time Frame: 1 year ]

Eligibility Criteria
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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
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.
Contacts and Locations
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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


Contacts
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Contact: Qiang Fu, Master 86-27-63089811 yunr777@yahoo.com.cn

Locations
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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         
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Principal Investigator: Shiying Yu, Master Tongji Cancer Center
More Information
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Publications:
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.

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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
Keywords provided by Huazhong University of Science and Technology:
gastric cancer
sequence chemoradiotherapy
OLF regimen
survival rate
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases