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Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neoadjuvant chemoradiation
Upfront surgery
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreas, cancer, borderline resectable, locally advanced, resectability, chemotherapy, radiation, chemoradiation, neoadjuvant, survival, prognosis, recurrence, response rate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Liver Cancer, National Cancer Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Samsung Medical Center
  • Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neoadjuvant

Upfront surgery

Arm Description

Neoadjuvant - operation - maintenance chemotherapy

Operation - adjuvant chemoradiation - maintenance chemotherapy

Outcomes

Primary Outcome Measures

2-year survival rate
2-year actual survival outcome

Secondary Outcome Measures

Median survival
calculated from overall survival with Kaplan-Meier method
1-year survival rate
1-year actual survival rate
R0 resection rate
according to pathology report after operation
curative resection rate
according to pathology report after operation
local recurrence
any point during the follow-up period
response rate after neoadjuvant chemoradiation
comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation
efficacy of imaging study after neoadjuvant chemoradiation
comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation

Full Information

First Posted
October 19, 2011
Last Updated
April 30, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01458717
Brief Title
Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
Official Title
Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III 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.
Detailed Description
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III 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. This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreas, cancer, borderline resectable, locally advanced, resectability, chemotherapy, radiation, chemoradiation, neoadjuvant, survival, prognosis, recurrence, response rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant
Arm Type
Experimental
Arm Description
Neoadjuvant - operation - maintenance chemotherapy
Arm Title
Upfront surgery
Arm Type
Active Comparator
Arm Description
Operation - adjuvant chemoradiation - maintenance chemotherapy
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant chemoradiation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Upfront surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
2-year survival rate
Description
2-year actual survival outcome
Time Frame
2-year actual survival outcome
Secondary Outcome Measure Information:
Title
Median survival
Description
calculated from overall survival with Kaplan-Meier method
Time Frame
after at least of 2-years follow up of all participants
Title
1-year survival rate
Description
1-year actual survival rate
Time Frame
after at least of 1-year follow up of all participants
Title
R0 resection rate
Description
according to pathology report after operation
Time Frame
within 3 weeks after operation
Title
curative resection rate
Description
according to pathology report after operation
Time Frame
within 3 weeks after operation
Title
local recurrence
Description
any point during the follow-up period
Time Frame
within at least 2-years follow up
Title
response rate after neoadjuvant chemoradiation
Description
comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation
Time Frame
within 6 weeks after completion of neoadjuvant chemoradiation
Title
efficacy of imaging study after neoadjuvant chemoradiation
Description
comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation
Time Frame
within 3 weeks after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Young Jang, M.D., Ph.D.
Organizational Affiliation
Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Liver Cancer, National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

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