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)
- Conditions
- R0/R1 resected ductal pancreatic adenocarcinomaMedDRA version: 20.0Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-004802-14-PL
- Lead Sponsor
- Klinikum der Universität München - Anstalt des öffentlichen Rechts
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 336
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. Postoperative tumor marker (CEA/CA19-9) = 2.5 x upper limit of normal (ULN)
to be documented within 1 week prior to randomization
6. Performance status ECOG 0-2
7. Adequate bone marrow function defined as
- WBC count = 3.5 x 10^9/L and
- platelets = 150 x 10^9/L and
- haemoglobin = 9 g/dl
documented within 1 week prior to randomization
8. Adequate renal function defined as
- serum creatinine = 1.2 mg/dL and
- calculated GFR = 60 mL/min documented within 1 week prior to randomization
9. Adequate coagulatory function defined as
- Quick-value = 70% and
- aPTT = 1.5 x ULN
documented within 1 week prior to randomization
10. Transaminases (AST, ALT) = 3 x ULN and bilirubin = 2 x ULN documented within 1 week prior to randomization
11. At least 18 years of age
12. 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.)
13. 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)
14. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Improvement of the outcome of resectable pancreatic carcinoma through an as compared to standard therapy intensified adjuvant treamtent with gemcitabine, cisplatin and regional deep hyperthermia;Secondary Objective: Comparison of the both treatment arms with regard to<br>– overall survival (OS)<br>– quality of life<br>- toxicity profile<br>;Primary end point(s): Comparison of disease free survival (DSF) in both treatment arms (GPH and GC);Timepoint(s) of evaluation of this end point: Tumor assessments will be done after course 3 or if disease recurrence is suspected, at the end of the study (= 4 weeks after the final dose) and at 3 monthly intervals during Follow Up.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Comparison of the both treatment arms with regard to:<br>- overall survival<br>- quality of life<br>- toxicity profile;Timepoint(s) of evaluation of this end point: - Overall survival will be evaluated during treatment on D1, 2, 3, 8, 15, 16, 17 and 22 of every 28 day-course, at the end of the study (= 4 weeks after last dose) and at 3 monthly intervals during Follow Up.<br>- Quality of life will be evaluated during treatment on D1 and D15, at the end of the study and at 3 monthly intervals during Follow Up<br>- Toxicity profile will be evaluated during treatment on D1, 2, 3, 8, 15, 16, 17 and 22 of every 28 day-course and at the end of the study