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Hyperthermia European Adjuvant Trial (HEAT)
This study is not yet open for participant recruitment.
Verified by Klinikum der Universitaet Muenchen, Grosshadern, March 2010
First Received: February 25, 2010   Last Updated: March 15, 2010   History of Changes
Sponsor: Klinikum der Universitaet Muenchen, Grosshadern
Collaborators: European Society for Hyperthermic Oncology
Institute for Medical Informatics, Biometry and Epidemiology, Munich
ClinAssess GmbH, Leverkusen, Germany
Information provided by: Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier: NCT01077427
  Purpose

The addition of regional hyperthermia to standard chemotherapy (gemcitabine) in an adjuvant setting may improve the outcome of patients with pancreatic cancer. The present trial is performed in order to confirm the hypothesis that the addition of regional hyperthermia (RHT) to gemcitabine standard therapy (G + RHT) for pancreatic cancer patients after R0/R1-tumor resection is superior to gemcitabine standard therapy alone (G).


Condition Intervention Phase
Pancreatic Adenocarcinoma
Device: Gemcitabine + regional hyperthermia
Drug: Gemcitabine
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Active Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open Multicenter Trial of Adjuvant Gemcitabine Chemotherapy With the Addition of Regional Hyperthermia in First-line Treatment of Patients With R0/R1 Resected Pancreatic Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: Interim analyses after 26 and 39 months after start of the study; final analysis after 60 months after start of the study; follow-up every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Interim analyses after 26 and 39 months after start of the study; final analysis after 60 months after start of the study; follow-up every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 366
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gemcitabine: Active Comparator
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course
Drug: Gemcitabine
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course
Gemcitabine + regional hyperthermia: Experimental
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course Regional hyperthermia: 60 minutes / 42˚C on days 2, 9, and 16 of each course
Device: Gemcitabine + regional hyperthermia
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course Regional hyperthermia: 60 minutes / 42˚C on days 2, 9, and 16 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:

  1. any ductal adenocarcinoma of the pancreas confirmed by histology
  2. previous R0 or R1 resection of pancreatic tumor with a standardized procedure
  3. no other previous or concomitant treatment of pancreatic carcinoma like radiation, chemotherapy or immunotherapy
  4. no macroscopic manifestation of pancreatic cancer detectable by CT/MRT after surgery
  5. postoperative tumor marker (CEA/CA19-9) <= 2.5 x upper limit of normal (ULN) to be documented within 1 week prior to randomization
  6. performance status ECOG 0-2
  7. 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
  8. adequate renal function defined as

    • serum creatinine <= 1.5 ULN
    • calculated GFR >= 60 mL/min
  9. adequate coagulatory function defined as

    • Quick-value >= 70%
    • aPTT <= 1.5 x ULN documented within 1 week prior to randomization
  10. transaminases (AST, ALT) <= 3xULN and bilirubin <= 2xULN
  11. between at least 18 years and 75 years of age
  12. 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).
  13. 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)
  14. documentation of written informed consent

Exclusion Criteria:

  1. cystic carcinoma of the pancreas
  2. periampullary cancer
  3. presence of an active infection grade 3 or higher
  4. other severe disease which could impair the patient's ability to participate in the trial according to the investigator's opinion
  5. pregnant or breastfeeding women
  6. contraindication with regard to standard gemcitabine
  7. severe, non-healing wounds, ulcers or bone fractures
  8. participation in another clinical trial during this trial or within 4 weeks prior to randomization
  9. past or current abuse of illegal or legal drugs or alcohol
  10. 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).
  11. permanent cardiac pacemaker
  12. treatment with regional hyperthermia not possible for technical reasons (e.g. metal implant, gross adiposity)
  13. cirrhosis of liver (Child index B and C)
  14. current severe coronary heart disease or heart insufficiency (NYHA class III and IV)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077427

Contacts
Contact: Rolf D. Issels, MD, PhD +49-89-7095-4768 Rolf.Issels@med.uni-muenchen.de

Locations
Germany, Bavaria
Hospital of the University of Munich
Munich, Bavaria, Germany, 81377
Sponsors and Collaborators
Klinikum der Universitaet Muenchen, Grosshadern
European Society for Hyperthermic Oncology
Institute for Medical Informatics, Biometry and Epidemiology, Munich
ClinAssess GmbH, Leverkusen, Germany
Investigators
Principal Investigator: Rolf D. Issels, MD, PhD Hospital of the University of Munich, Campus Grosshadern, Germany
  More Information

No publications provided

Responsible Party: Klinikum der Universitaet Muenchen, Grosshadern ( Rolf D. Issels, MD, PhD )
ClinicalTrials.gov Identifier: NCT01077427     History of Changes
Other Study ID Numbers: 115-09
Study First Received: February 25, 2010
Last Updated: March 15, 2010
Health Authority: Germany: Ethics Committee of Hospital of the University of Munich

Keywords provided by Klinikum der Universitaet Muenchen, Grosshadern:
Pancreas
Cancer
Adenocarcinoma
R0 or R1 resected ductal pancreatic adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Fever
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Body Temperature Changes
Signs and Symptoms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 01, 2010