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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01396668
First received: July 1, 2011
Last updated: July 15, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
 Drug: gemcitabine, cisplatin, capecitabine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    number of patients who experienced grade 3-4 toxicity by NCI-CTCAE

  • 1 year survival rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    response rate by RECIST criteria

  • overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • clinical benefit rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    CR+PR+SD by RECIST criteria


Estimated Enrollment: 35
Study Start Date: December 2004
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: gemcitabine, cisplatin, capecitabine
    Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396668

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Seock-Ah Im, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seock-Ah Im, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01396668     History of Changes
Other Study ID Numbers: H-0412-138-005
Study First Received: July 1, 2011
Last Updated: July 15, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
locally advanced

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
Capecitabine
Cisplatin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013