Pancreatic Neoplasms
Conditions
Keywords
locally advanced pancreatic cancer, chemotherapy, stereotactic radiotherapy
Brief summary
The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an increase in survival.
Interventions
RADIATIONstereotactic radiotherapy
Sponsors
Erasmus Medical Center
Foundation for Liver Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 \< 7 cm x 7 cm x 7 cm * Normal renal function (Creatinine ≥ 30 ml/min). * Normal liver tests (bilirubin \< 1.5 times normal; ALAT/ASAT \< 5 times normal) * Normal bone marrow function (WBC \> 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
* 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 | up to 3.5 years after start of therapy |
Secondary
| Measure | Time frame |
|---|---|
| radiological response rates after chemotherapy and radiotherapy | up to 3.5 years after start of therapy |
| number of resections at end of stereotactic radiotherapy | up to 3.5 years after start of therapy |
| number of toxicity events related to chemotherapy | up to 3.5 years after start of therapy |
| time to development of distant metastases | up to 3.5 years after start of therapy |
| predictive value of a set of biological markers for treatment response | up to 3.5 years after start of therapy |
| time to locoregional disease progression | up to 3.5 years after start of therapy |
Countries
Netherlands
Outcome results
None listed