locally advanced pancreatic carcinoma Pancreatic cancer
Conditions
Interventions
Up to 8 cycles of systemic chemotherapy with FOLFIRINOX followed by 5 days of
stereotactic radiotherapy. After cycle 4 and 8 of chemotherapy a CT scan will
be performed in order to rule out the deve
Sponsors
Stichting Leveronderzoek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Cytological or Histologically confirmed 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
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 |
|---|---|
| The main endpoints are defined as overall survival (OS), time to progression (TTP) and toxicity of stereotactic radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: radiological response, resectability and progression (local as well as distant) | — |
Countries
Netherlands
Outcome results
None listed