Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT02459652|
Recruitment Status : Unknown
Verified June 2016 by Japan Adjuvant Study Group of Pancreatic Cancer.
Recruitment status was: Active, not recruiting
First Posted : June 2, 2015
Last Update Posted : June 29, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: S-1 Radiation: Radiation Therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||September 2018|
Experimental: Neoadjuvant S-1/RT
This is a single arm prospective study. All eligible subjects will receive neoadjuvant S-1 and concurrent radiation followed by surgical resection. Subjects may receive adjuvant chemotherapy after surgical resection at the clinical discretion of the medical oncologists.
S-1 is administered orally at a dose of 40 mg/m2 twice daily on the day of irradiation (Monday through Friday) during radiation therapy.
Radiation: Radiation Therapy
Radiation therapy is delivered with >6-megavolts (MV) photons, using a multiple field technique. A total dose of 50.4 Gy is delivered in 28 fractions over 5.5 weeks.
- R0 resection rate [ Time Frame: Up to 4 years ]R0 resection rate of all patients enrolled in the study
- Overall survival [ Time Frame: up to 6 years ]
- Disease-free survival [ Time Frame: up to 6 years ]
- Response rate after neoadjuvant chemoradiation [ Time Frame: Up to 4 years ]All responses will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 within 4 weeks after completion of neoadjuvant therapy.
- Pathological response rate [ Time Frame: Up to 4 years ]Evaluation of the pathological response of the primary tumor was performed using a classification by Evans et al.
- 2-year survival rate [ Time Frame: up to 6 years ]
- Surgical morbidity rates [ Time Frame: With in 90 days ]Both Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and Clavien-Dindo Classification will be used for all morbidity assessments.
- Acute and late toxicity rates [ Time Frame: With in 6 months ]All toxicities will be measured by CTCAE version 4.0.
- R0 resection rate in borderline resectable pancreatic cancer [ Time Frame: Up to 4 years ]Diagnosis of borderline resectable pancreatic cancer will be fixed by Diagnostic Radiology Central Review.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459652
|Aichi Cancer Center|
|Nagoya, Aichi, Japan, 464-8681|
|Nagoya University Hospital|
|Nagoya, Aichi, Japan, 466-8560|
|Hirosaki University Hospital|
|Hirosaki, Aomori, Japan, 036-8563|
|National Cancer Center Hospital East|
|Kashiwa, Chiba, Japan, 277-8577|
|Shikoku Cancer Center|
|Matsuyama, Ehime, Japan, 791-0280|
|Fukuyama City Hospital|
|Fukuyama, Hiroshima, Japan, 721-8511|
|National Hospital Organization Kure Medical Center|
|Kure, Hiroshima, Japan, 737-0023|
|Asahikawa Medical University|
|Asahikawa, Hokkaido, Japan, 078-8510|
|Hokkaido University Hospital|
|Sapporo, Hokkaido, Japan, 060-8648|
|Kobe University Hospital|
|Kobe, Hyogo, Japan, 650-0017|
|St. Marianna University School of Medicine Hospital|
|Kawasaki, Kanagawa, Japan, 216-8511|
|Kanagawa Cancer Center|
|Yokohama, Kanagawa, Japan, 241-8515|
|National Hospital Organization Osaka National Hospital|
|Chuo-ku, Osaka, Japan, 540-0006|
|Saitama Cancer Center|
|Kita-adachigun Inamachi, Saitama, Japan, 362-0806|
|Seirei Mikatahara General Hospital|
|Hamamatsu, Shizuoka, Japan, 433-8558|
|Shizuoka Cancer Center|
|Suntohgun, Nagaizumityo, Shizuoka, Japan, 411-8777|
|Jichi Medical University Hospital|
|Shimotsuke, Tochigi, Japan, 329-0498|
|Tochigi Cancer Center|
|Utsunomiya, Tochigi, Japan, 320-0834|
|Tokyo Women's Medical University Hospital|
|Shinjuku, Tokyo, Japan, 162-8666|
|Chiba Cancer Center|
|Chiba, Japan, 260-8717|
|National Hospital Organization Kyusyu Cancer Center|
|Fukuoka, Japan, 811-1395|
|Yamagata University Hospital|
|Yamagata, Japan, 990-9585|
|Principal Investigator:||Masafumi Ikeda, M.D., Ph.D.||National Cancer Center Hospital East, Department of Hepatobiliary Pancreatic Oncology|
|Study Chair:||Katsuhiko Uesaka, M.D., Ph.D.||Shizuoka Cancer Center Hospital|