Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer. (LAPC-1)

Foundation for Liver Research

Status

Completed

Conditions

Pancreatic Neoplasms

Treatments

Radiation: stereotactic radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02292745

2014- 00235039

2014-002350-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.