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

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ClinicalTrials.gov Identifier: NCT01396668
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : July 19, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine, cisplatin, capecitabine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2004
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine



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)


Primary Outcome Measures :
  1. Time to progression [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. safety [ Time Frame: 12 months ]
    number of patients who experienced grade 3-4 toxicity by NCI-CTCAE

  2. 1 year survival rate [ Time Frame: 1 year ]
  3. response rate [ Time Frame: 1 year ]
    response rate by RECIST criteria

  4. overall survival [ Time Frame: 1 year ]
  5. clinical benefit rate [ Time Frame: 1 year ]
    CR+PR+SD by RECIST criteria



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Seock-Ah Im, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01396668     History of Changes
Other Study ID Numbers: H-0412-138-005
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

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
Cisplatin
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs