Hyperthermia European Adjuvant Trial (HEAT)

This study is currently recruiting participants.
Verified July 2012 by Klinikum der Universitaet Muenchen, Grosshadern
Sponsor:
Collaborators:
The European Society for Hyperthermic Oncology
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Rolf D. Issels, Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier:
NCT01077427
First received: February 25, 2010
Last updated: July 18, 2012
Last verified: July 2012
  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:


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 ]

Other Outcome Measures:
  • Toxicity [ Time Frame: Permanent assessment ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: Permanent assessment ] [ Designated as safety issue: No ]
    EORTC QLQ C30


Estimated Enrollment: 336
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 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 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


  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, neoadjuvant therapy or immunotherapy
  4. No tumor recurrence 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

    • WBC count ≥ 3.5 x 109/L and
    • platelets ≥ 150 x 109/L and
    • haemoglobin ≥ 9 g/dl documented within 1 week prior to randomization
  8. Adequate renal function defined as

    • serum creatinine ≤ 1.2 mg/dL and
    • calculated GFR ≥ 60 mL/min documented within 1 week prior to randomization
  9. Adequate coagulatory function defined as

    • Quick-value ≥ 70% and
    • aPTT ≤ 1.5 x ULN documented within 1 week prior to randomization
  10. Transaminases (AST, ALT) ≤ 3 x ULN and bilirubin ≤ 2 x ULN documented within 1 week prior to randomization
  11. At least 18 years of age
  12. Women with childbearing potential and fertile men must use adequate contraceptive measures during and for at least 3 months (female) and 6 months (male) after completion of study 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. Written informed consent

Exclusion criteria:

  1. Cystic carcinoma of the pancreas
  2. Periampullary, papillary cancer
  3. Metastatic disease
  4. Presence of an active infection grade 3 or higher
  5. Other severe disease which could impair the patient's ability to participate in the study according to the investigator's opinion
  6. Pregnant or breastfeeding women
  7. Known allergies or contraindications with regard to substances or procedures of study therapy
  8. Severe, non-healing wounds, ulcers or bone fractures
  9. Participation in another clinical trial during this study or within 4 weeks prior to randomization
  10. Past or current abuse of illegal or legal drugs or alcohol
  11. 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).
  12. Permanent cardiac pacemaker
  13. Gross adiposity defined as BMI > 40 kg/m²
  14. 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
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:
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: July 18, 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
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 20, 2014