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Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Huazhong University of Science and Technology.
Recruitment status was:  Not yet recruiting
Information provided by:
Huazhong University of Science and Technology Identifier:
First received: April 23, 2009
Last updated: September 8, 2010
Last verified: September 2010
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 Intervention Phase
Gastric Cancer
Radiation: sequence chemoradiotherapy
Drug: chemotherapy alone following radical resection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer

Resource links provided by NLM:

Further study details as provided by Huazhong University of Science and Technology:

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

Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01197118

Contact: Qiang Fu, Master 86-27-63089811

China, Hubei
Tongji Cancer Center,Tongji Hospital Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: Qiang Fu, Master    86-27-83663342   
Contact: Shiying Yu, Master    86-27-83663342   
Principal Investigator: Shiying Yu, Master         
Sub-Investigator: Qiang Fu, Master         
Sponsors and Collaborators
Huazhong University of Science and Technology
Principal Investigator: Shiying Yu, Master Tongji Cancer Center
  More Information

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.

Responsible Party: Shiying Yu / Chief, Tongji Cancer Center Identifier: NCT01197118     History of Changes
Other Study ID Numbers: TJCC-GC001
Study First Received: April 23, 2009
Last Updated: September 8, 2010

Keywords provided by Huazhong University of Science and Technology:
gastric cancer
sequence chemoradiotherapy
OLF regimen
survival rate

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 21, 2017