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Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gemcitabine, cisplatin, capecitabine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring locally advanced

Eligibility Criteria

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

Inclusion Criteria:

  • unresectable locally advanced pancreatic cancer
  • no distant metastasis
  • histologically confirmed adenocarcinoma of pancreas
  • 18-75 of age
  • ECOG performance status 0-2

  • normal marrow function :

    • WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3
    • Platelet count at least 100,000/mm3

  • normal liver function :

    --Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN)

  • normal renal function :

    --Creatinine no greater than 1.5 times ULN

  • signed informed consent

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University Hospital

Outcomes

Primary Outcome Measures

Time to progression

Secondary Outcome Measures

safety
number of patients who experienced grade 3-4 toxicity by NCI-CTCAE
1 year survival rate
response rate
response rate by RECIST criteria
overall survival
clinical benefit rate
CR+PR+SD by RECIST criteria

Full Information

First Posted
July 1, 2011
Last Updated
July 15, 2011
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01396668
Brief Title
Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer
Official Title
Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.
Detailed Description
The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
locally advanced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine, cisplatin, capecitabine
Intervention Description
Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)
Primary Outcome Measure Information:
Title
Time to progression
Time Frame
12 months
Secondary Outcome Measure Information:
Title
safety
Description
number of patients who experienced grade 3-4 toxicity by NCI-CTCAE
Time Frame
12 months
Title
1 year survival rate
Time Frame
1 year
Title
response rate
Description
response rate by RECIST criteria
Time Frame
1 year
Title
overall survival
Time Frame
1 year
Title
clinical benefit rate
Description
CR+PR+SD by RECIST criteria
Time Frame
1 year

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: unresectable locally advanced pancreatic cancer no distant metastasis histologically confirmed adenocarcinoma of pancreas 18-75 of age ECOG performance status 0-2 normal marrow function : WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 normal liver function : --Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN) normal renal function : --Creatinine no greater than 1.5 times ULN signed informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seock-Ah Im, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer

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