A Phase II Study of Locally Advanced Pancreatic Cancer

Sponsor
National Health Research Institutes, Taiwan
Study ID
NCT01867892
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT — DRUG
    oxapliplatin ,irinotecan ,5FU +leucovorin ,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly
  • ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT — DRUG
    Gem ,Oxa ,5FU +LV ,RT 5,040cGy in 28 fractions/5.5 wks and Gem 400mg/m2 iv 40min weekly

Study Details

The primary end point is to evaluate the 9-month progression free survival rate and safety profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer. The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.

Key Dates

Start date
Jun 30, 2013
Status verified
May 2013
Primary completion
May 31, 2018
Completion
May 31, 2019

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ICT of oxaliplatin,irinotecan,5-FU and leucovorinon and CCRT
    Arm1:oxaliplatin,irinotecan,5-FU and leucovorinon D1,15 every 28days for 3 cycles,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly
  • Active Comparator: ICT of gemcitabine,oxaliplatin,5-FU,leucovorin and CCRT
    Arm 2:gemcitabine,oxaliplatin,5-FU,leucovorin on D1,15 every 28 days for 3 cycles,Evaluation of Tumor Response,CR/PR/SD or localized disease RT 5,040cGy in 28 fractions/ 5.5 wks Arm 2: Gem 400mg/m2 iv 40min weekly

Primary Outcome Measure

the response rate, disease control rate, overall survival, and patients' quality of life. [ Time Frame: 4.5 years ]

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