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Brief Title: Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer
Official Title: Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion
Study ID: NCT01381913
Brief Summary: Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. This feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.
Detailed Description: 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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kita, Kagawa, Japan
Name: Shinichi Yachida, M. D. Ph. D.
Affiliation: Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan
Role: STUDY_DIRECTOR
Name: Yasuyuki Suzuki, M. D. Ph. D.
Affiliation: Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan
Role: PRINCIPAL_INVESTIGATOR