Efficacy And Feasibility Of Combining FOLFIRINOX And Stereotactic Radiotherapy For Patients With Irresectable Locally Advanced Pancreatic Cancer.

Study Overview

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.

N/A

Pancreatic Neoplasms

RADIATION: stereotactic radiotherapy

2014- 00235039
2014-002350-39 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-07-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-07-28
First Submitted that Met QC Criteria 2014-11-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-07-29
First Posted (ACTUAL) 2014-11-17	Results First Posted N/A	Last Verified 2020-07

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Stereotactic radiotherapy

Standard of care FOLFIRINOX treatment followed by stereotactic radiotherapy

RADIATION: stereotactic radiotherapy

Primary Outcome Measures	Measure Description	Time Frame
overall survival		up to 3.5 years after start of therapy

Secondary Outcome Measures	Measure Description	Time Frame
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
number of resections at end of stereotactic radiotherapy		up to 3.5 years after start of therapy
time to locoregional disease progression		up to 3.5 years after start of therapy
time to development of distant metastases		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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

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

Erasmus Medical Center

Investigators

PRINCIPAL_INVESTIGATOR: Prof. C.H.J. van Eijck, MD, PhD, Erasmus Medical Center

Publications

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

General Publications

Suker M, Nuyttens JJ, Eskens FALM, Haberkorn BCM, Coene PLO, van der Harst E, Bonsing BA, Vahrmeijer AL, Mieog JSD, Jan Swijnenburg R, Roos D, Koerkamp BG, van Eijck CHJ. Efficacy and feasibility of stereotactic radiotherapy after folfirinox in patients with locally advanced pancreatic cancer (LAPC-1 trial). EClinicalMedicine. 2019 Nov 19;17:100200. doi: 10.1016/j.eclinm.2019.10.013. eCollection 2019 Dec.

Learn

Resources

Patients

Caregivers

Clinical Trial Record