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Clinical Trial Record

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Hyperthermia European Adjuvant Trial

2012-03

2019-03

2021-03

336

Study Overview

Hyperthermia European Adjuvant Trial

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.

N/A

  • Resected Pancreatic Adenocarcinoma
  • DEVICE: Gemcitabine + Cisplatin + regional hyperthermia
  • DRUG: Gemcitabine + Capecitabine
  • 115-09
  • 2008-004802-14 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )
  • AIO-PAK-0111 (OTHER Identifier) (OTHER: Arbeitsgemeinschaft Internistische Onkologie (AIO))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2010-02-25  

N/A  

2017-11-14  

2010-02-26  

N/A  

2017-11-17  

2010-03-01  

N/A  

2017-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Gemcitabine + Capecitabine

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
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*
Primary Outcome MeasuresMeasure DescriptionTime Frame
Disease-free survival (DFS)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
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Overall survival (OS)From date of randomization until the date of death from any cause assessed up to 60 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Rolf D. Issels, MD, PhD

Phone Number: +49-89-4400-77776

Email: heat@med.uni-muenchen.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • 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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Issels RD, Boeck S, Pelzer U, Mansmann U, Ghadjar P, Lindner LH, Albertsmeier M, Angele MK, Schmidt M, Xu Y, Bahra M, Pratschke J, Schoenberg M, Thasler WE, Salat C, Stoetzer OJ, Knoefel WT, Graf D, Wessalowski R, Keitel-Anselmino V, Koenigsrainer A, Bitzer M, Zips D, Bamberg M, Fietkau R, Ott O, Kawecki M, Wyrwicz L, Rutkowski P, Rentsch M, Ababei J, Reichardt P, Rigamonti M, Weber B, Abdel-Rahman S, Tschoep-Lechner K, Jauch KW, Bruns CJ, Oettle H, von Bergwelt-Baildon M, Heinemann V, Werner J; European Society for Hyperthermic Oncology (ESHO) and the German Arbeitsgemeinschaft Internistische Onkologie (AIO) Study Group for Pancreatic Cancer. Regional hyperthermia with cisplatin added to gemcitabine versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma: The HEAT randomised clinical trial. Eur J Cancer. 2023 Mar;181:155-165. doi: 10.1016/j.ejca.2022.12.009. Epub 2022 Dec 30.
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