Status:
COMPLETED
Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Lead Sponsor:
Foundation for Liver Research
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2018
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02292745
Start Date
December 2 2014
End Date
May 24 2018
Last Update
July 29 2020
Active Locations (1)
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1
Erasmus MC
Rotterdam, Netherlands, 3015 CE