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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Capecitabine
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014