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Hyperthermia European Adjuvant Trial (HEAT)

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ClinicalTrials.gov Identifier: NCT01077427
Recruitment Status : Recruiting
First Posted : March 1, 2010
Last Update Posted : November 17, 2017
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

Tracking Information
First Submitted Date  ICMJE February 25, 2010
First Posted Date  ICMJE March 1, 2010
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
Overall survival (OS) [ Time Frame: From date of randomization until the date of death from any cause assessed up to 60 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
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 ]
Current Other Pre-specified Outcome Measures
 (submitted: July 18, 2012)
  • Toxicity [ Time Frame: Permanent assessment ]
  • Quality of Life [ Time Frame: Permanent assessment ]
    EORTC QLQ C30
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperthermia European Adjuvant Trial
Official Title  ICMJE 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)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Resected Pancreatic Adenocarcinoma
Intervention  ICMJE
  • 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

Study Arms  ICMJE
  • Active Comparator: Gemcitabine + Capecitabine
    Intervention: Drug: Gemcitabine + Capecitabine
  • Experimental: Gemcitabine + Cisplatin + regional hyperthermia
    Intervention: Device: Gemcitabine + Cisplatin + regional hyperthermia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2012)
336
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2010)
366
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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"
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rolf D. Issels, MD, PhD +49-89-4400-77776 heat@med.uni-muenchen.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01077427
Other Study ID Numbers  ICMJE 115-09
2008-004802-14 ( EudraCT Number )
AIO-PAK-0111 ( Other Identifier: Arbeitsgemeinschaft Internistische Onkologie (AIO) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rolf D. Issels, Klinikum der Universitaet Muenchen, Grosshadern
Study Sponsor  ICMJE Klinikum der Universitaet Muenchen, Grosshadern
Collaborators  ICMJE
  • The European Society for Hyperthermic Oncology
  • Ludwig-Maximilians - University of Munich
Investigators  ICMJE
Principal Investigator: Rolf D. Issels, MD, PhD Klinikum Grosshadern, Medical Center, University of Munich, Germany
PRS Account Klinikum der Universitaet Muenchen, Grosshadern
Verification Date November 2017

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