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Hyperthermia European Adjuvant Trial

NCT01077427 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2017-11-17

No results posted yet for this study

Summary

Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia as compared to standard chemotherapy.

Conditions

  • Resected Pancreatic Adenocarcinoma

Interventions

DEVICE

Gemcitabine + Cisplatin + regional hyperthermia

Gemcitabine: 1000 mg/m² as iv-infusion on days 1 and 15 of each course (Total dose: 12 g/m²) Cisplatin: 25 mg/m² as iv-infusion on days 2, 3\* and 16, 17\* of each course (Total dose: 600 mg/m²) Regional hyperthermia: 60 minutes on days 2, 3\*, and 16, 17\* of each course \* as an exception for medical or logistic reasons RHT and cisplatin can be applied day 4 instead of 3 and day 18 instead of 17

DRUG

Gemcitabine + Capecitabine

Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 18 g/m²) Capecitabine: daily dose of 1660 mg/m²; administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles

Sponsors & Collaborators

  • The European Society for Hyperthermic Oncology

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Klinikum der Universitaet Muenchen, Grosshadern

    lead OTHER

Principal Investigators

  • Rolf D. Issels, MD, PhD · Klinikum Grosshadern, Medical Center, University of Munich, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2019-03-31
Completion
2021-03-31

Countries

  • Germany

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 NCT01077427 on ClinicalTrials.gov