Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Radiation: stereotactic radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic radiotherapy<br>Standard of care FOLFIRINOX treatment followed by stereotactic radiotherapy | Radiation: stereotactic radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | up to 3.5 years after start of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| number of resections at end of stereotactic radiotherapy |  | up to 3.5 years after start of therapy | 
| time to locoregional disease progression |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced pancreatic cancer, chemotherapy, stereotactic radiotherapy