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Hyperthermia European Adjuvant Trial (HEAT)

This study is currently recruiting participants.
Verified November 2017 by Rolf D. Issels, Klinikum der Universitaet Muenchen, Grosshadern
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077427
First Posted: March 1, 2010
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
February 25, 2010
March 1, 2010
November 17, 2017
March 2012
March 2019   (Final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01077427 on ClinicalTrials.gov Archive Site
Overall survival (OS) [ Time Frame: From date of randomization until the date of death from any cause assessed up to 60 months ]
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 ]
  • Toxicity [ Time Frame: Permanent assessment ]
  • Quality of Life [ Time Frame: Permanent assessment ]
    EORTC QLQ C30
Not Provided
 
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Resected Pancreatic Adenocarcinoma
  • 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

  • Active Comparator: Gemcitabine + Capecitabine
    Intervention: Drug: Gemcitabine + Capecitabine
  • Experimental: Gemcitabine + Cisplatin + regional hyperthermia
    Intervention: Device: Gemcitabine + Cisplatin + regional hyperthermia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
336
March 2021
March 2019   (Final data collection date for primary outcome measure)

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. Performance status ECOG 0-2
  6. 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
  7. Adequate renal function defined as

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

    • Quick-value ≥ 70% and
    • aPTT ≤ 1.5 x ULN documented within 1 week prior to randomization
  9. Transaminases (AST, ALT) ≤ 3 x ULN and bilirubin ≤ 2 x ULN documented within 1 week prior to randomization
  10. At least 18 years of age
  11. 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.)
  12. 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)
  13. 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 (Exception: participation in a surgical trial prior to this study, for instance RECOPANC trial, comparing two different surgical procedures of pancreas resection)
  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. Clinically significant cardiovascular or vascular disease or disorder ≤ 6 months before study enrolment (e.g. myocardial infarction, unstable angina pectoris, chronic heart failure NYHA ≥ grade 2, uncontrolled arrhythmia, cerebral infarction
  14. Gross adiposity defined as BMI > 40 kg/m²
  15. Treatment with regional hyperthermia not possible for technical reasons (e.g. metal implant)
  16. "Known documented dihydropyrimidine dehydrogenase (DPD) deficiency"
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Rolf D. Issels, MD, PhD +49-89-4400-77776 heat@med.uni-muenchen.de
Germany
 
 
NCT01077427
115-09
2008-004802-14 ( EudraCT Number )
AIO-PAK-0111 ( Other Identifier: Arbeitsgemeinschaft Internistische Onkologie (AIO) )
Yes
Not Provided
Not Provided
Rolf D. Issels, Klinikum der Universitaet Muenchen, Grosshadern
Klinikum der Universitaet Muenchen, Grosshadern
  • The European Society for Hyperthermic Oncology
  • Ludwig-Maximilians - University of Munich
Principal Investigator: Rolf D. Issels, MD, PhD Klinikum Grosshadern, Medical Center, University of Munich, Germany
Klinikum der Universitaet Muenchen, Grosshadern
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP