Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
sequence chemoradiotherapy
chemotherapy alone following radical resection
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, sequence chemoradiotherapy, OLF regimen, survival rate
Eligibility Criteria
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.
Sites / Locations
- Tongji Cancer Center,Tongji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2
1
Arm Description
chemotherapy alone following radical resection
sequence chemoradiotherapy following radical resection
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT01197118
First Posted
April 23, 2009
Last Updated
September 8, 2010
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01197118
Brief Title
Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer
Official Title
Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, sequence chemoradiotherapy, OLF regimen, survival rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
chemotherapy alone following radical resection
Arm Title
1
Arm Type
Experimental
Arm Description
sequence chemoradiotherapy following radical resection
Intervention Type
Radiation
Intervention Name(s)
sequence chemoradiotherapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
chemotherapy alone following radical resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Fu, Master
Phone
86-27-63089811
Email
yunr777@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiying Yu, Master
Organizational Affiliation
Tongji Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Cancer Center,Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Fu, Master
Phone
86-27-83663342
Email
yunr777@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Shiying Yu, Master
Phone
86-27-83663342
Email
syyu@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shiying Yu, Master
First Name & Middle Initial & Last Name & Degree
Qiang Fu, Master
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
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Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer
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