Clinical trial NCT01077427: Hyperthermia European Adjuvant Trial
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Resected Pancreatic Adenocarcinoma
Keywords: pancreatic cancer
adjuvant treatment
hyperthermia
Lead sponsor: Klinikum der Universitaet Muenchen, Grosshadern
Sponsor class: OTHER
Collaborators: name: The European Society for Hyperthermic Oncology
name: Ludwig-Maximilians - University of Munich
First posted: 2010-03-01
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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"

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 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 outcomes:
measure: Overall survival (OS)
timeFrame: From date of randomization until the date of death from any cause assessed up to 60 months
Other outcomes:
measure: Toxicity
timeFrame: Permanent assessment
measure: Quality of Life
timeFrame: Permanent assessment
Locations:
city: Munich
country: Germany
facility: Klinikum Grosshadern, Medical Center, University of Munich
state: Bavaria
Study officials:
affiliation: Klinikum Grosshadern, Medical Center, University of Munich, Germany
name: Rolf D. Issels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: