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

Phase 2

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT01396668
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-07
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-15
• Last Update Submitted: 2011-07-15
• Study First Posted: 2011-07-19
• Last Update Posted: 2011-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time to progression	12 months

Secondary Outcome Measures

Name	Time	Method
safety	12 months	number of patients who experienced grade 3-4 toxicity by NCI-CTCAE
1 year survival rate	1 year
response rate	1 year	response rate by RECIST criteria
overall survival	1 year
clinical benefit rate	1 year	CR+PR+SD by RECIST criteria

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of