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JOURNAL ONKOLOGIE – STUDIE
HEAT

Hyperthermia European Adjuvant Trial

Rekrutierend

NCT-Nummer:
NCT01077427

Studienbeginn:
März 2012

Letztes Update:
17.11.2017

Wirkstoff:
Gemcitabine + Capecitabine

Indikation (Clinical Trials):
Adenocarcinoma, Fever

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Klinikum der Universitaet Muenchen, Grosshadern

Collaborator:
The European Society for Hyperthermic Oncology, Ludwig-Maximilians - University of Munich,

Studienleiter

Rolf D. Issels, MD, PhD
Principal Investigator
Klinikum Grosshadern, Medical Center, University of Munich, Germany

Kontakt

Studienlocations
(1 von 1)

Klinikum Grosshadern, Medical Center, University of Munich
81377 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Rolf D. Issels, MD, PhD
Phone: +49-89-4400-77776
E-Mail: heat@med.uni-muenchen.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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"

Studien-Rationale

Primary outcome:

1. 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)



Secondary outcome:

1. Overall survival (OS) (Time Frame - From date of randomization until the date of death from any cause assessed up to 60 months)

Studien-Arme

  • Active Comparator: Gemcitabine + Capecitabine
  • Experimental: Gemcitabine + Cisplatin + regional hyperthermia

Geprüfte Regime

  • 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

Quelle: ClinicalTrials.gov


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