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Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

This study is currently recruiting participants.
Verified March 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jin-Young Jang, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01458717
First received: October 19, 2011
Last updated: March 17, 2013
Last verified: March 2013
History of Changes
  Purpose

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.


Condition Intervention Phase
Pancreatic Cancer
 Drug: Neoadjuvant chemoradiation
Procedure: Upfront surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Prospective Randomized Phase II Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 2-year survival rate [ Time Frame: 2-year actual survival outcome ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median survival [ Time Frame: after at least of 2-years follow up of all participants ] [ Designated as safety issue: No ]
    calculated from overall survival with Kaplan-Meier method

  • 1-year survival rate [ Time Frame: after at least of 1-year follow up of all participants ] [ Designated as safety issue: No ]
    1-year actual survival rate

  • R0 resection rate [ Time Frame: within 3 weeks after operation ] [ Designated as safety issue: No ]
    according to pathology report after operation

  • curative resection rate [ Time Frame: within 3 weeks after operation ] [ Designated as safety issue: No ]
    according to pathology report after operation

  • local recurrence [ Time Frame: within at least 2-years follow up ] [ Designated as safety issue: No ]
    any point during the follow-up period

  • response rate after neoadjuvant chemoradiation [ Time Frame: within 6 weeks after completion of neoadjuvant chemoradiation ] [ Designated as safety issue: No ]
    comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation

  • efficacy of imaging study after neoadjuvant chemoradiation [ Time Frame: within 3 weeks after operation ] [ Designated as safety issue: No ]
    comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation


Estimated Enrollment: 116
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neoadjuvant
Neoadjuvant - operation - maintenance chemotherapy
 Drug: Neoadjuvant chemoradiation
  • Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡
  • 4 weeks rest, re-evaluation for resectability
  • operation
  • start maintenance chemotherapy within 4~6 weeks after operation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
Other Name: Neoadjuvant chemoradiation
Active Comparator: Upfront surgery
Operation - adjuvant chemoradiation - maintenance chemotherapy
 Procedure: Upfront surgery
  • Operation at time of diagnosis
  • Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡
  • start maintenance chemotherapy within 4~6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
Other Name: Upfront surgery

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years old or <75 years old
  • ECOG 0-2
  • biopsy proven adenocarcinoma of the pancreas
  • no history of previous chemotherapy
  • borderline resectable pancreas cancer
  • no distant metastasis
  • WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
  • Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal
  • Creatinine no greater than 1.5 times upper limit of normal
  • informed consent

Exclusion Criteria:

  • history of previous chemotherapy
  • history of radiation at >25% area of bone marrow
  • stage unspecified, with distant metastasis, recurrent pancreas cancer
  • history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study
  • pregnant, breast-feeding patient
  • uncontrolled or active infection
  • uncontrolled cardiopulmonary disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458717

Contacts
Contact: Jin-Young Jang, M.D., Ph.D. 82-2-2072-2194 jangjy4@snu.ac.kr
Contact: Ye Rim Chang, M.D. 82-2-2072-1959 yerimchang@gmail.com

Locations
Korea, Republic of
Center for Liver Cancer, National Cancer Center Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Contact: Sang-Jae Park, M.D., Ph.D.         spark@ncc.re.kr    
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: Jai Young Cho, M.D., Ph.D.         jycho@snubh.org    
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jin-Young Jang, M.D., Ph.D.     82-2-2072-2194     jangjy4@snu.ac.kr    
Sub-Investigator: Yung-Jue Bang            
Sub-Investigator: Seock-Ah Im            
Sub-Investigator: Do-Youn Oh            
Sub-Investigator: Sae-Won Han            
Sub-Investigator: Kyung-Hun Lee            
Sub-Investigator: Eui Kyu Chie            
Sub-Investigator: Kyubo Kim            
Sub-Investigator: Jeong Min Lee            
Sub-Investigator: Sun-Whe Kim            
Sub-Investigator: Mee Joo Kang            
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Sung Ho Choi, M.D., Ph.D.         pancreas@skku.edu    
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Joon Seong Park, M.D., Ph.D.         jspark330@yuhs.ac    
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jin-Young Jang, M.D., Ph.D. Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Jin-Young Jang, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01458717     History of Changes
Other Study ID Numbers: BorderlinePancreas
Study First Received: October 19, 2011
Last Updated: March 17, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
pancreas
cancer
borderline resectable
locally advanced
resectability
chemotherapy
radiation
 chemoradiation
neoadjuvant
survival
prognosis
recurrence
response rate

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013