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

July 28, 2020 updated by: Foundation for Liver Research
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereotactic radiotherapy
Standard of care FOLFIRINOX treatment followed by stereotactic radiotherapy
Radiation: stereotactic radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: up to 3.5 years after start of therapy
up to 3.5 years after start of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
number of toxicity events related to chemotherapy
Time Frame: up to 3.5 years after start of therapy
up to 3.5 years after start of therapy
radiological response rates after chemotherapy and radiotherapy
Time Frame: up to 3.5 years after start of therapy
up to 3.5 years after start of therapy
number of resections at end of stereotactic radiotherapy
Time Frame: up to 3.5 years after start of therapy
up to 3.5 years after start of therapy
time to locoregional disease progression
Time Frame: up to 3.5 years after start of therapy
up to 3.5 years after start of therapy
time to development of distant metastases
Time Frame: up to 3.5 years after start of therapy
up to 3.5 years after start of therapy
predictive value of a set of biological markers for treatment response
Time Frame: up to 3.5 years after start of therapy
up to 3.5 years after start of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Liver Research

Collaborators

Erasmus Medical Center

Investigators

  • Principal Investigator: Prof. C.H.J. van Eijck, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2014

Primary Completion (Actual)

May 24, 2018

Study Completion (Actual)

May 24, 2018

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014- 00235039
  • 2014-002350-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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