Hyperthermia European Adjuvant Trial - Full Text View

Sponsor:	Klinikum der Universitaet Muenchen, Grosshadern
Collaborators:	The European Society for Hyperthermic Oncology Institute of Medical Informatics, Biometry, and Epidemiology, Ludwig-Maximilians-University of Munich
Information provided by (Responsible Party):	Rolf D. Issels, Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier:	NCT01077427

Purpose

Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with additional application of cisplatin and regional deep hyperthermia.

Condition	Intervention	Phase
Resected Pancreatic Adenocarcinoma	Device: Gemcitabine + Cisplatin + regional hyperthermia Drug: Gemcitabine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Alone (Arm G) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)

Resource links provided by NLM:

MedlinePlus related topics: Fever Pancreatic Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Klinikum der Universitaet Muenchen, Grosshadern:

Primary Outcome Measures:

Disease-free survival (DFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival (OS) [ Time Frame: From date of randomization until the date of death from any cause assessed up to 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	366
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2017
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Gemcitabine Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 18 g/m²)	Drug: Gemcitabine Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 18 g/m²)
Experimental: Gemcitabine + Cisplatin + regional hyperthermia Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 12 g/m²) Cisplatin: 25 mg/m² as iv-infusion on days 2, 4 and 16, 18 of each course (Total dose: 600 mg/m²) Regional hyperthermia: 60 minutes on days 2, 4, and 16, 18 of each course	Device: Gemcitabine + Cisplatin + regional hyperthermia Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 12 g/m²) Cisplatin: 25 mg/m² as iv-infusion on days 2, 4 and 16, 18 of each course (Total dose: 600 mg/m²) Regional hyperthermia: 60 minutes on days 2, 4, and 16, 18 of each course

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

any ductal adenocarcinoma of the pancreas confirmed by histology
previous R0 or R1 resection of pancreatic tumor with a standardized procedure
no other previous or concomitant treatment of pancreatic carcinoma like radiation, chemotherapy or immunotherapy
no macroscopic manifestation of pancreatic cancer detectable by CT/MRT after surgery
postoperative tumor marker (CEA/CA19-9) <= 2.5 x upper limit of normal (ULN) to be documented within 1 week prior to randomization
performance status ECOG 0-2
adequate bone marrow function defined as
- leucocytes >= 3.5 x 109/L
- thrombocytes >= 150 x 109/L
- hemoglobin >= 9 g/dl
documented within 1 week prior to randomization
adequate renal function defined as
- serum creatinine <= 1.5 ULN
- calculated GFR >= 60 mL/min
adequate coagulatory function defined as
- Quick-value >= 70%
- aPTT <= 1.5 x ULN
documented within 1 week prior to randomization
transaminases (AST, ALT) <= 3xULN and bilirubin <= 2xULN
between at least 18 years and 75 years of age
women with childbearing potential and fertile men must use adequate contraceptive measures during and for at least 3 months after completion of trial therapy (Adequate methods for women are oral contraceptives with estrogen and progesterone, vaginal rings, contraceptive patches, estrogen-free ovulation inhibitors, intrauterine devices with progesterone, 3-month injections with depot progesterone, implants setting free progesterone, abstinence or sterilization (vasectomy) of the male partner. Men must use condoms).
women with childbearing potential must have a negative pregnancy test within 1 week prior to randomization (postmenopausal women with amenorrhea for more than 1 year are regarded as having no childbearing potential)
documentation of written informed consent

Exclusion Criteria:

cystic carcinoma of the pancreas
periampullary cancer
presence of an active infection grade 3 or higher
other severe disease which could impair the patient's ability to participate in the study according to the investigator's opinion
pregnant or breastfeeding women
known allergies or contraindications with regard to substances or procedures of study therapy
severe, non-healing wounds, ulcers or bone fractures
participation in another clinical trial during this study or within 4 weeks prior to randomization
past or current abuse of illegal or legal drugs or alcohol
other primary malignant diseases in the medical history during the last 5 years (exceptions: carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin).
permanent cardiac pacemaker
gross adiposity defined as BMI > 40 kg/m²
treatment with regional hyperthermia not possible for technical reasons (e.g. metal implant)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077427

Contacts

Contact: Rolf D. Issels, MD, PhD

+49-89-7095-7776

heat@med.uni-muenchen.de

Locations

Germany
Klinikum Grosshadern, Medical Center, University of Munich	Recruiting
Munich, Bavaria, Germany, 81377
Contact: Rolf D. Issels, MD, PhD +49-89-7095-7776 heat@med.uni-muenchen.de
Principal Investigator: Rolf D. Issels, MD, PhD

Sponsors and Collaborators

Klinikum der Universitaet Muenchen, Grosshadern

The European Society for Hyperthermic Oncology

Institute of Medical Informatics, Biometry, and Epidemiology, Ludwig-Maximilians-University of Munich

Investigators

Principal Investigator:

Rolf D. Issels, MD, PhD

Klinikum Grosshadern, Medical Center, University of Munich, Germany

More Information

Additional Information:

Pankreaszentrum München This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Rolf D. Issels, PhD, MD, Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier:	NCT01077427 History of Changes
Other Study ID Numbers:	115-09, 2008-004802-14, AIO-PAK-0111
Study First Received:	February 25, 2010
Last Updated:	March 9, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum der Universitaet Muenchen, Grosshadern:

pancreatic cancer
adjuvant treatment
hyperthermia

Additional relevant MeSH terms:

Adenocarcinoma
Fever
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Body Temperature Changes
Signs and Symptoms
Adjuvants, Immunologic
Gemcitabine
Cisplatin
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 23, 2012