locally advanced pancreatic cancer pancreatic neoplasm FOLFIRINOX stereotactic radiotherapy
Conditions
Interventions
stereotactic radiotherapy
Sponsors
Foundation for Liver and Gastrointestinal Research
Eligibility
Inclusion criteria
Inclusion criteria: - Cytological or histologically confirmation of pancreatic cancer. - WHO performance status of 0 or 1 - ASA classification I or II - Tumor considered locally advanced after diagnostic work-up including CT-imaging and diagnostic laparoscopy. - No evidence of metastatic disease - Largest tumor diameter 3.0 x 10e9/L, platelets > 100 x 10e9/L and hemoglobin > 5.6 mmol/l) - Age > 18 years and < 75 years - Written informed consent
Exclusion criteria
Exclusion criteria: - Prior radiotherapy, chemotherapy or resection (bypass surgery allowed). - Lymph node metastases from primary tumor outside the field of radiation. - Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence. - Pregnancy, breast feeding. - Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| - number of toxicity events related to chemotherapy - radiological response after chemotherapy and radiotherapy - number of resections at end of stereotactic radiotherapy - time to locoregional disease progression - time to development of distant metastases - predictive value of a set of biological markers for treatment response (miRNAs) | — |
Contacts
Public ContactC.H.J. van Eijck
Erasmus MC, department of Surgery
Outcome results
None listed