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

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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
Sponsor:
Collaborators:
Japan Agency for Medical Research and Development
Pharma Valley Center
Information provided by (Responsible Party):
Japan Adjuvant Study Group of Pancreatic Cancer

Tracking Information
First Submitted Date  ICMJE May 29, 2015
First Posted Date  ICMJE June 2, 2015
Last Update Posted Date June 29, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2015)
R0 resection rate [ Time Frame: Up to 4 years ]
R0 resection rate of all patients enrolled in the study
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02459652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
Official Title  ICMJE Phase II Study of Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: S-1
  • Radiation: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 29, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02459652
Other Study ID Numbers  ICMJE JASPAC 05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Japan Adjuvant Study Group of Pancreatic Cancer
Study Sponsor  ICMJE Japan Adjuvant Study Group of Pancreatic Cancer
Collaborators  ICMJE
  • Japan Agency for Medical Research and Development
  • Pharma Valley Center
Investigators  ICMJE
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
PRS Account Japan Adjuvant Study Group of Pancreatic Cancer
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP