C25.0
Conditions
Interventions
Group 1: Neoadjuvant CRT with weekly Gemcitabine 300mg/m2 for 6 weeks combined with external beam radiotherapy (EBRT) delivering a total dose of 50.4 Gy over 28 days in 1.8 Gy fractions will be follow
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Histology-proven adenocarcinoma of the pancreatic head/uncinate process with a tumor size greater 2 cm (=cT2) and/or close contact to the superior mesenteric vessels (=3 mm in preoperative staging). • No evidence of metastasis to distant organs (liver, peritoneum, lung, others). • For determination of resectability, a multi-detector CT (MDCT) with at least 16 rows applying both oral and intravenous contrast media is performed. MDCT-based imaging focuses on the upper abdomen with native, arterial, and parenchyma phase, where the parenchyma phase should include the pelvis. Imaging criteria derived from the recent consensus definition of the Society of Surgical Oncology, the American Society of Clinical Oncology and the American Hepato-Pancreatico-Biliary Association are applied for preoperative assessment of local resectability. • Potential Resectability: visualizable fat plane around celiac and superior mesenteric arteries, and patent superior mesenteric/portal vein (SMV/PV). • Borderline Resectability: substantial superior mesenteric/portal vein impingement, tumor abutment on the SMA 10.0 mg/dl undergo preoperative biliary decompression, preferentially by interventional endoscopy) • White blood cell count > 3.5 x 109/ml, platelet count > 100 x 109/ml • Ability to understand and willingness to consent to formal requirements for study participation • Written informed consent
Exclusion criteria
Exclusion criteria: • Age 1.5; other severe diseases that might prevent completion of the treatment regimen) • Chronic infectious diseases, especially immune deficiency syndromes, e.g. HIV infection, active tuberculosis within 12 months prior to potential study participation • Severe neurologic disorders, e.g. cerebrovascular ischemia • History of prior deep venous thrombosis or pulmonary embolism Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months following the trial • Serious medical, psychological, familial, sociological or geographical conditions or circumstances potentially hampering compliance with the study protocol and follow-up • Participation in other clinical trials during the last 6 months before allocation to trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival time (3-year survival rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Histology-proven R0 resection rate based on a standardized histopathological handling of the surgical specimen. 2. Frequency of moderate and severe toxicity events and drop-out rate due to therapy related toxicity (NCI Common Toxicity Criteria v4.0) 3. Resectability rate (Note: includes both R0 and R1 resection status) 4. Rate of unexpected intraoperative irregularities, operative time, blood transfusion requirement, postoperative morbidity rate, especially that of pancreatic fistula, and mortality rate 5. Rate of patients with severe postoperative complications (postop. recovery > 8 weeks) rendering adjuvant treatment worthless 6. Disease progression during neoadjuvant therapy 7. Quality of life analysis (EORTC QLQ C30 questionnaire). After completion of neoadj. RCTx, postoperative, 6, 12 and 18 months after completion of therapy. 8. Median disease-free survival (DFS, local and distant), overall survival (OS) (3-year follow-up) 9. First site of tumor recurrence | — |
Countries
Germany
Contacts
Public ContactFlorian Gebauer
Universitätsklinikum Hamburg-Eppendorf Klinik für Allgemein- Viszeral- und Thoraxchirurgie
Outcome results
None listed