Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion|
|Study Start Date:||October 2005|
|Study Completion Date:||May 2011|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|