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

History of Changes

Purpose

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 Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Sodium polystyrene sulfonate

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]


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

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

Eligibility


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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197118

Contacts


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

Locations


China, Hubei
Tongji Cancer Center,Tongji Hospital	Not yet recruiting
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


Principal Investigator:	Shiying Yu, Master	Tongji Cancer Center

More Information

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.


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

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 Neoplasms Digestive System Diseases	Gastrointestinal Diseases Stomach Diseases Polystyrene sulfonic acid Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016

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