Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie
- Determine the clinical response rate in patients undergoing surgery for locally
advanced pancreatic cancer treated with stereotactic radiotherapy, gemcitabine
hydrochloride, and oxaliplatin.
- Determine the toxicity of this regimen in these patients.
- Determine the time to disease progression in patients treated with this regimen.
- Determine the time to death in patients treated with this regimen.
- Determine perioperative morbidity and mortality in patients treated with this regimen.
- Determine the rate of R0 resections in patients treated with this regimen.
- Determine the histologic response rate in these patients.
- Neoadjuvant therapy: Patients undergo hypofractionated, stereotactic radiotherapy on
days 1-5. Patients also receive gemcitabine hydrochloride IV over 100 minutes on day 1
and oxaliplatin IV over 120 minutes on day 2. Treatment with gemcitabine hydrocloride
and oxaliplatin repeats every 2 weeks for 3 courses.
- Surgery: Patients with resectable disease undergo tumor resection. Patients with
unresectable disease undergo a second course of neoadjuvant chemoradiotherapy followed
- Adjuvant therapy: Beginning 3-4 weeks after surgery, patients receive 3 more courses of
chemotherapy as in neoadjuvant therapy.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Clinical response rate as assessed by RECIST criteria
Florian Lordick, MD
Technische Universität München
Germany: Federal Institute for Drugs and Medical Devices