Timing Of Start Of SystemIc Treatment For Asymptomatic Metastasized Pancreatic Cancer

Study Overview

Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer

Since patients with metastatic pancreatic cancer have a limited life expectancy, it is important to determine the timing of when to start chemotherapy in order to optimize the benefits of chemotherapy relative to the side effects. Therefore, two treatment strategies can be considered: chemotherapy started immediately at diagnosis, or delayed until disease-related symptoms occur.

N/A

Metastatic Pancreas Cancer

DRUG: Folfirinox

NL722253.018.19

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 2021-05-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-05-18
First Submitted that Met QC Criteria 2021-05-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-05-24
First Posted (ACTUAL) 2021-05-24	Results First Posted N/A	Last Verified 2021-05

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:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Immediate treatment The treatment schedule will be direct (start within 3 weeks of bate of diagnosis) FOLFIRINOX or nab paclitaxel in combination with gemcitabine per investigator's choice. Dosage and frequency of administration will be according to local protocol.	DRUG: Folfirinox In both arms the intervention will be FOLRINIOX or nab paclitaxel in combination with gemcitabine per investigator's choice
ACTIVE_COMPARATOR: Delayed treatment The treatment schedule will be delayed treatment (based on symptoms) with FOLFIRINOX or nab paclitaxel in combination with gemcitabine per investigator's choice. Dosage and frequency of administration will be according to local protocol. Chemotherap	DRUG: Folfirinox In both arms the intervention will be FOLRINIOX or nab paclitaxel in combination with gemcitabine per investigator's choice

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Immediate treatment

The treatment schedule will be direct (start within 3 weeks of bate of diagnosis) FOLFIRINOX or nab paclitaxel in combination with gemcitabine per investigator's choice. Dosage and frequency of administration will be according to local protocol.

DRUG: Folfirinox

In both arms the intervention will be FOLRINIOX or nab paclitaxel in combination with gemcitabine per investigator's choice

ACTIVE_COMPARATOR: Delayed treatment

The treatment schedule will be delayed treatment (based on symptoms) with FOLFIRINOX or nab paclitaxel in combination with gemcitabine per investigator's choice. Dosage and frequency of administration will be according to local protocol. Chemotherap

DRUG: Folfirinox

In both arms the intervention will be FOLRINIOX or nab paclitaxel in combination with gemcitabine per investigator's choice

Primary Outcome Measures	Measure Description	Time Frame
Quality adjusted overall survival	Measured in "utility-per-month", using the survival in months and the monthly reported quality of life by the EQ-5D-5L questionaire.	From date of randomization until the date of death, assessed up to 12 months

Secondary Outcome Measures	Measure Description	Time Frame
Time to disease progression	Restricted mean progression free survival (RM-PFS): are under the Kaplan-Meier PFS curve between randomization and follow-up of the study (estimated 12 months)	12 months
Quality adjusted progression free survival (PFS)		From date of randomization until the date of death, assessed up to 12 months
Duration of time without symptoms of disease progression or toxicities (TWiST)		From date of randomization until the date of death, assessed up to 12 months
Overall survival	(In months)	From date of randomization until the date of death, assessed up to 12 months
Number of patients with adverse events	According to NCI CTC version 5.0	From date of randomization until the date of death, assessed up to 12 months

Contacts and Locations

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

Study Contact

Name: J.W. Wilmink, Dr.

Phone Number: +31 20 5628065

Email: [email protected]

Study Contact Backup

Name: S. Augustinus

Phone Number:

Email: [email protected]

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:

Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
Patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma.
Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria.
Eastern Cooperative Oncology Group Performance Status of 0-1
Life expectancy ≥ 3 months.
Age ≥ 18 years.
A negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication) if female subject is of childbearing potential.
Screening clinical laboratory values as follows:

No symptoms related to advanced disease, specified as:

No prior chemotherapy for metastatic disease (patients might have received adjuvant treatment more than 6 months before the development of metastatic disease, or neoadjuvant treatment before surgery for resectable disease)

Known central nervous system involvement or brain metastases.
New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months
Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications.
Inability to comply with study and follow-up procedures as judged by the Investigator.
Women currently pregnant or breastfeeding.

Collaborators and Investigators

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

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

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record