Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Huazhong University of Science and Technology.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01197118
First received: April 23, 2009
Last updated: September 8, 2010
Last verified: September 2010

April 23, 2009
September 8, 2010
September 2010
December 2010   (final data collection date for primary outcome measure)
overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01197118 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer
Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • 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

  • 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.
  • Active Comparator: 2
    chemotherapy alone following radical resection
    Intervention: Drug: chemotherapy alone following radical resection
  • Experimental: 1
    sequence chemoradiotherapy following radical resection
    Intervention: Radiation: sequence chemoradiotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
May 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Qiang Fu, Master 86-27-63089811 yunr777@yahoo.com.cn
China
 
NCT01197118
TJCC-GC001
No
Shiying Yu / Chief, Tongji Cancer Center
Huazhong University of Science and Technology
Not Provided
Principal Investigator: Shiying Yu, Master Tongji Cancer Center
Huazhong University of Science and Technology
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP