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Completed

NCT Number: NCT01396668

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemcitabine, cisplatin, capecitabine

Drug

Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)

Primary outcomes

  1. Time to progression

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Jul 19, 2011
Registry last updated
Jul 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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