Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Conditions
Pancreatic Neoplasms
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
locally advanced pancreatic cancer, chemotherapy, stereotactic radiotherapy
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: stereotactic radiotherapy
Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Erasmus MC
Rotterdam, Netherlands
Status: Recruiting
Start Date
November 2014
Completion Date
November 2020
Sponsors
Foundation for Liver Research
Source
Foundation for Liver Research
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page