Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT01381913|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
|Condition or disease|
|Gastric Cancer Chemoradiation|
Since S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) was approved in Japan in 1999 after a large-scale clinical trial, adjuvant chemotherapy with S-1 has been the standard treatment for stage II/III gastric cancer. However, for far-advanced gastric cancer, various adjuvant chemotherapies, including S-1, have not achieved satisfactory results. Therefore, Japan Clinical Oncology Group (JCOG) is currently performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) for locally far-advanced gastric cancer. However, previous studies of NAC have reported a pathological response rate of 15-50% for the main lesion, indicating no significant effect on local tumor control.
On the other hand, other studies have reported that anticancer drugs, including S-1, have a radiosensitizing effect, and that neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. Therefore, we conducted a feasibility trial of NACRT with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion.
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Observational Model:||Case Control|
|Official Title:||Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||May 2011|
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): NCT01381913
|Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University|
|Kita, Kagawa, Japan, 761-0793|
|Study Director:||Shinichi Yachida, M. D. Ph. D.||Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan|
|Principal Investigator:||Yasuyuki Suzuki, M. D. Ph. D.||Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan|