NCT01077427

Hyperthermia European Adjuvant Trial

A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Plus Capecitabine (Arm GC) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Klinikum der Universitaet Muenchen, Grosshadern · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-03-01
• Primary completion: 2019-03-01
• Completion: 2021-03-01
• First posted: 2010-03-01
• Last updated: 2017-11-17

Locations

1 site across 1 country: Germany