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Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Japan Agency for Medical Research and Development
Pharma Valley Center
Information provided by (Responsible Party):
Japan Adjuvant Study Group of Pancreatic Cancer

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: S-1 Radiation: Radiation Therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: 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: 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.

Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: Up to 4 years ]
    R0 resection rate of all patients enrolled in the study

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 6 years ]
  2. Disease-free survival [ Time Frame: up to 6 years ]
  3. 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.

  4. 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.

  5. 2-year survival rate [ Time Frame: up to 6 years ]
  6. 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.

  7. Acute and late toxicity rates [ Time Frame: With in 6 months ]
    All toxicities will be measured by CTCAE version 4.0.

  8. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cytologic or histologic proof of pancreatic ductal carcinoma or adenosquamous carcinoma is required prior to study entry.
  • 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:

  • Tumor invasion to the alimentary tract determined by abdominal CT scan or endoscopic examination
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02459652

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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
Sponsors and Collaborators
Japan Adjuvant Study Group of Pancreatic Cancer
Japan Agency for Medical Research and Development
Pharma Valley Center
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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

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Responsible Party: Japan Adjuvant Study Group of Pancreatic Cancer Identifier: NCT02459652     History of Changes
Other Study ID Numbers: JASPAC 05
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Keywords provided by Japan Adjuvant Study Group of Pancreatic Cancer:
Borderline Resectable Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases