Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer

NCT04897854 | Unknown Phase 3 DMC

• 1 other identifier: NL722253.018.19
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to disease progression

  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

  From date of randomization until the date of death, assessed up to 12 months

• Number of patients with adverse events

  From date of randomization until the date of death, assessed up to 12 months

Other Outcomes (1)

• Level of CA 19.9

  From date of randomization until the date of death, assessed up to 12 months

Study Arms (2)

Immediate treatment

ACTIVE COMPARATOR

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

Delayed treatment

ACTIVE COMPARATOR

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. Chemotherapy will start as soon as one of the following criteria is met: * Decline in performance status to ECOG \< 1 or Karnofsky \< 80% * Weight loss more than 5% of the total body weight from the time of study entry * Persistent nausea requiring medication * Pain requiring regular narcotic analgesics * Development of clinically significant third-space fluid collections * Liver function deterioration in the presence of progressive liver metastases

Drug: Folfirinox

Interventions

Folfirinox DRUG

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

Delayed treatment; Immediate treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count \> 1.5 x 109 /L
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN).
• Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN, (if liver metastases are present, then ≤ 5 times ULN is allowed).
• Serum creatinine \< 1.5 x ULN or creatinine clearance \>50 mL/min/1.73 m2
• Prothrombin time/international normalized ratio within normal limits (± 15%) or within therapeutic range if subject takes warfarin. Partial thromboplastin time (PTT) within normal limits (± 15%).
• Platelet count \> 100,000 x 109 /L
• No symptoms related to advanced disease, specified as:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

J.W. Wilmink, Dr.

CONTACT

+31 20 5628065; j.w.wilmink@amsterdamumc.nl

S. Augustinus

CONTACT

s.augustinus@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. J.W. Wilmink, MD, PhD, Principal Investigator, Amsterdam UMC

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 24, 2021
• Study Start: April 22, 2021
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)