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A Phase II Study of Locally Advanced Pancreatic Cancer

NCT01867892 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2013-06-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT

oxapliplatin ,irinotecan ,5FU +leucovorin ,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly

DRUG

ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT

Gem ,Oxa ,5FU +LV ,RT 5,040cGy in 28 fractions/5.5 wks and Gem 400mg/m2 iv 40min weekly

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Yen-Shen Shen, M.D. · National Cheng-Kung University Hospital

  • Chih-Hung Hsu, Ph.D. · National Taiwan University Hospital

  • Ruey-Kuen Hsieh, M.D. · Mackay Memorial Hospital

  • Jen-Shi Chen, M.D. · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2018-05-31
Completion
2019-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867892 on ClinicalTrials.gov