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A Study of Locally Advanced Pancreatic Cancer

NCT01063192 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2010-02-05

No results posted yet for this study

Summary

The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination 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

Gemcitabine

Arm 1: Gemcitabine alone on D1,8,15 every 28 days for 3 cycles

DRUG

Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL)

Arm 2: GOFL on D1, 15 every 28 days for 3 cycles(Gem 800mg/m2 80min, Oxa 85mg/m2 2hr, 5FU 3000mg/m2, LV 150mg/m2 iv 48hr)

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Pin-Wen Lin, M.D · National Cheng-Kung University Hospital

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

  • Chiun Hsu, Ph.D. · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-09-30
Completion
2016-09-30

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Drugs
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 NCT01063192 on ClinicalTrials.gov