NCT02292745CompletedNot Applicable
Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Foundation for Liver Research2 sites in 1 country53 target enrollmentStarted: December 2, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- overall survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
overall survival
Time Frame: up to 3.5 years after start of therapy
Secondary Outcomes
- time to development of distant metastases(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)
- radiological response rates after chemotherapy and radiotherapy(up to 3.5 years after start of therapy)
- time to locoregional disease progression(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)
- number of resections at end of stereotactic radiotherapy(up to 3.5 years after start of therapy)
Investigators
Study Sites (2)
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