Hyperthermia European Adjuvant Trial (HEAT)

Klinikum der Universitaet Muenchen, Grosshadern

Status and phase: Unknown; Phase 3

Conditions: Resected Pancreatic Adenocarcinoma

Treatments: Device: Gemcitabine + Cisplatin + regional hyperthermia; Drug: Gemcitabine + Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01077427

115-09

2008-004802-14 (EudraCT Number)

AIO-PAK-0111 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 336 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 2 patient groups

Gemcitabine + Capecitabine

Active Comparator group

Treatment:

Drug: Gemcitabine + Capecitabine

Gemcitabine + Cisplatin + regional hyperthermia

Experimental group

Treatment:

Device: Gemcitabine + Cisplatin + regional hyperthermia