Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
336 participants
INTERVENTIONAL
2012-03-31
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemcitabine + Capecitabine
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
Gemcitabine + Cisplatin + regional hyperthermia
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
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
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"
18 Years
75 Years
ALL
No
Sponsors
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The European Society for Hyperthermic Oncology
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Klinikum der Universitaet Muenchen, Grosshadern
OTHER
Responsible Party
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Rolf D. Issels
MD, PhD
Principal Investigators
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Rolf D. Issels, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Grosshadern, Medical Center, University of Munich, Germany
Locations
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Klinikum Grosshadern, Medical Center, University of Munich
Munich, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Rolf D. Issels, MD, PhD
Role: primary
References
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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.
Related Links
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Pankreaszentrum München
Other Identifiers
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2008-004802-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AIO-PAK-0111
Identifier Type: OTHER
Identifier Source: secondary_id
115-09
Identifier Type: -
Identifier Source: org_study_id