Skip to main content
Clinical Trials/NCT02292745
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

Sponsor
Foundation for Liver Research
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials