Skip to main content
OpenTrials
Completed

NCT Number: NCT02292745

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic radiotherapy

Radiation

Primary outcomes

  1. overall survival

    Time frame: up to 3.5 years after start of therapy

Secondary outcomes

  1. number of toxicity events related to chemotherapy

    Time frame: up to 3.5 years after start of therapy

  2. radiological response rates after chemotherapy and radiotherapy

    Time frame: up to 3.5 years after start of therapy

  3. number of resections at end of stereotactic radiotherapy

    Time frame: up to 3.5 years after start of therapy

  4. time to locoregional disease progression

    Time frame: up to 3.5 years after start of therapy

  5. time to development of distant metastases

    Time frame: up to 3.5 years after start of therapy

  6. predictive value of a set of biological markers for treatment response

    Time frame: up to 3.5 years after start of therapy

Sponsors and collaborators

Lead sponsor

Foundation for Liver Research

Other

Collaborators

  • Erasmus Medical Center

Registry information

Acronym: LAPC-1

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2014
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.