Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
NCT ID: NCT02459652
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2012-12-28
2018-07-17
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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 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.
Interventions
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S-1
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 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.
Eligibility Criteria
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Inclusion Criteria
* Disease assessment by Multi Detector-row Computed Tomography (MDCT) scan within 2 weeks of study entry
* Borderline resectable pancreatic cancer
* No evidence of metastatic disease as determined by chest CT scan, and abdominal CT scan and laparoscopy. Paraaortic lymph node metastasis is considered as metastatic.
* Age \>/=20 years old, \</=75 years old
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* No prior chemotherapy or radiotherapy for pancreatic cancer
* A square 10 x 10 cm radiation field could encompass all pancreatic lesions and lymph node metastases
* Adequate oral intake
* Appropriate biliary drainage for obstructive jaundice
* Lab Values:
* hemoglobin concentration \>/= 9.0 g/dL
* leukocyte count \>/= 3,000/mm3
* platelet count \>/= 100,000/mm3
* serum total bilirubin \</= 2.0 mg dL, or \</=3.0 mg/dL with biliary drainage
* Aspartate Transaminase (AST) and Alanine Transaminase (ALT) \</= 100 U/L, or \</= 150 U/L with biliary drainage
* serum albumin \>/= 3.0 g/dl
* serum creatinine \</= 1.2 mg dL
* Creatinine clearance \>/= 50 ml/min
* Written informed consent
Exclusion Criteria
* Prior chemotherapy using fluoropyrimidine
* Prior radiation therapy to the abdomen
* Watery diarrhea
* Concurrent phenytoin, warfarin potassium, or flucytosine treatment
* Presence of contrast medium allergy
* Pulmonary fibrosis or interstitial pneumonia
* Pleural effusion or ascites
* Active infection
* Uncontrolled diabetes mellitus (FBS \>/= 200mg/dL or HbA1c \>/= 10.0)
* Active concomitant malignancy
* Active gastroduodenal ulcer
* Severe complications such as cardiac or renal disease
* Regular administration of systemic corticosteroid
* Psychiatric disorder
* History of drug hypersensitivity
* Pregnant and lactating women and women of childbearing age who were not using effective contraception
20 Years
75 Years
ALL
No
Sponsors
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Japan Agency for Medical Research and Development
OTHER_GOV
Pharma Valley Center
UNKNOWN
Japan Adjuvant Study Group of Pancreatic Cancer
OTHER
Responsible Party
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Principal Investigators
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Masafumi Ikeda, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center Hospital East, Department of Hepatobiliary Pancreatic Oncology
Katsuhiko Uesaka, M.D., Ph.D.
Role: STUDY_CHAIR
Shizuoka Cancer Center Hospital
Locations
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Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 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, Hyōgo, 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
Countries
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References
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Takahashi S, Ohno I, Ikeda M, Kobayashi T, Akimoto T, Kojima M, Konishi M, Uesaka K. Neoadjuvant S-1 with concurrent radiotherapy followed by surgery for borderline resectable pancreatic cancer: study protocol for an open-label, multicentre, prospective phase II trial (JASPAC05). BMJ Open. 2017 Oct 22;7(10):e018445. doi: 10.1136/bmjopen-2017-018445.
Takahashi S, Ohno I, Ikeda M, Konishi M, Kobayashi T, Akimoto T, Kojima M, Morinaga S, Toyama H, Shimizu Y, Miyamoto A, Tomikawa M, Takakura N, Takayama W, Hirano S, Otsubo T, Nagino M, Kimura W, Sugimachi K, Uesaka K. Neoadjuvant S-1 With Concurrent Radiotherapy Followed by Surgery for Borderline Resectable Pancreatic Cancer: A Phase II Open-label Multicenter Prospective Trial (JASPAC05). Ann Surg. 2022 Nov 1;276(5):e510-e517. doi: 10.1097/SLA.0000000000004535. Epub 2020 Oct 15.
Other Identifiers
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JASPAC 05
Identifier Type: -
Identifier Source: org_study_id