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Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study

NCT02439593 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2017-08-01

No results posted yet for this study

Summary

This is a phase II randomized study of concurrent chemoradiotherapy and local hyperthermia (study group) versus chemoradiotherapy alone (control group) following neoadjuvant chemotherapy in locally advanced pancreatic cancer. Each of the treatment arm would have 39 patients based on the expected overall 1 year survival advantage of +20% over the control group (p0=40%).

Conditions

  • Cancer Pancreas

Interventions

OTHER

Chemoradiotherapy (CTRT)

CTRT arm: Locoregional radiotherapy along with concurrent weekly gemcitabine

OTHER

Thermochemoradiotherapy (CTRTHT)

Locoregional hyperthermia with concurrent chemoradiotherapy with weekly gemcitabine

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • Kantonsspital Aarau

    lead OTHER

Principal Investigators

  • Niloy R Datta, MD,DNB · Kantonsspital Aarau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • Switzerland

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 NCT02439593 on ClinicalTrials.gov