Spots Global Cancer Trial Database for Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
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Trial Identification
Brief Title: Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
Official Title: Phase II Study of Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
Study ID: NCT02459652
Conditions
Study Description
Brief Summary: Multicenter Prospective Phase II Study for Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer RATIONALE: Borderline resectable pancreatic cancer is frequently related to a positive surgical margin and has a poor prognosis after resection. Neoadjuvant chemoradiation with intensive local effect may lead to substantial local control and prolongation of survival in borderline resectable pancreatic cancer. PURPOSE: This phase II trial assess efficacy and safety of neoadjuvant S-1 and concurrent radiotherapy for borderline resectable pancreatic cancer.
Detailed Description: S-1: S-1 is an oral fluorinated pyrimidine agent which contains tegafur (FT, a prodrug of 5-FU), 5-chloro-2,4-dihydropyrimidine (CHDP) and potassium oxonate (Oxo) effective for gastric and various other types of cancers. S-1 is also active for pancreatic cancer: S-1 demonstrated non-inferiority to gemcitabine in overall survival for metastatic or locally advanced pancreatic cancer (LAPC). S-1 and Concurrent radiotherapy: S-1 therapy with concurrent radiation therapy (RT) had favorable activity with overall tumor response rate of 37%, as well as mild toxicity in patients with LAPC. The median survival time and the 2-year survival rate for LAPC patients treated by S-1/RT were 16.2 months and 26% respectively. Definition of Borderline Resectable Pancreatic Cancer:(1) Reconstructible bilateral impingement of superior mesenteric vein or portal vein; (2) Tumor contact with the superior mesenteric artery (SMA) of \</= 180 degrees ; (3) Tumor contact with the common hepatic artery of \</= 180 degrees (at the root of the gastroduodenal artery); and (4) Tumor contact with the celiac axis of \</= 180 degrees. Tumor with portal vein tumor thrombus and tumor contact with the second or further jejunal SMA branch are considered as unresectable. Tumor which is contact with the common hepatic artery or celiac axis but can be resected by distal pancreatectomy with en bloc celiac axis resection, is not included in this study.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aichi Cancer Center, Nagoya, Aichi, Japan
Nagoya University Hospital, Nagoya, Aichi, Japan
Hirosaki University Hospital, Hirosaki, Aomori, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Shikoku Cancer Center, Matsuyama, Ehime, Japan
Fukuyama City Hospital, Fukuyama, Hiroshima, Japan
National Hospital Organization Kure Medical Center, Kure, Hiroshima, Japan
Asahikawa Medical University, Asahikawa, Hokkaido, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kobe University Hospital, Kobe, Hyogo, Japan
St. Marianna University School of Medicine Hospital, Kawasaki, Kanagawa, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
National Hospital Organization Osaka National Hospital, Chuo-ku, Osaka, Japan
Saitama Cancer Center, Kita-adachigun Inamachi, Saitama, Japan
Seirei Mikatahara General Hospital, Hamamatsu, Shizuoka, Japan
Shizuoka Cancer Center, Suntohgun, Nagaizumityo, Shizuoka, Japan
Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan
Tochigi Cancer Center, Utsunomiya, Tochigi, Japan
Tokyo Women's Medical University Hospital, Shinjuku, Tokyo, Japan
Chiba Cancer Center, Chiba, , Japan
National Hospital Organization Kyusyu Cancer Center, Fukuoka, , Japan
Yamagata University Hospital, Yamagata, , Japan
Contact Details
Name: Masafumi Ikeda, M.D., Ph.D.
Affiliation: National Cancer Center Hospital East, Department of Hepatobiliary Pancreatic Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Katsuhiko Uesaka, M.D., Ph.D.
Affiliation: Shizuoka Cancer Center Hospital
Role: STUDY_CHAIR
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