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Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma

NCT01593475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-01-03

No results posted yet for this study

Summary

This phase II trial chose the induction chemotherapy with gemcitabine and cisplatin followed by Chemoradiotherapy (CRT) with gemcitabine to optimize the treatment for pancreas cancer patients with locally advanced disease and the purpose of this trial is to evaluate the efficacy of induction CT with gemcitabine and cisplatin followed by CRT for unresectable pancreatic carcinoma.

Conditions

  • Pancreatic Carcinoma Non-resectable

Interventions

RADIATION

Induction chemotherapy followed by CCRT

Chemotherapy In one cycle (4-weeks), gemcitabine 1,000 mg/m2 will be given by 30-minute intravenous infusion on days 1, 8, and 15, and 1 hour infusion of CDDP was administered at a dose of 25 mg/m2 weekly diluted in 500 mL of normal saline to ensure adequate hydration 1 hour before the administration of gemcitabine. Gemcitabine 300mg/m2 will be given by 30-minute intravenous infusion weekly during CCRT will be started within 3 weeks after completion of 2 cycles of induction chemotherapy Radiotherapy \- Total dose of PGTV and PCTV were 55 Gy, 22 fractions and 44 Gy, 22 fractions, respectively.

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Woo Jin Lee, Ph.D · National Cancer Center, Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-05
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • South Korea

Study Locations

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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 NCT01593475 on ClinicalTrials.gov