To hear about similar clinical trials, please enter your email below
Trial Title:
Folinic Acid for Prevention of Pemetrexed-induced Toxicity
NCT ID:
NCT06010277
Condition:
NSCLC
Mesothelioma
Thymoma
Conditions: Official terms:
Mesothelioma
Thymoma
Leucovorin
Folic Acid
Levoleucovorin
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Folinic acid
Description:
Follow-up will take place during the first 4 cycles of chemotherapy with pemetrexed.
Patients in the intervention-arm will receive oral folinic acid orally 4 times 45mg / day
for 3 days, starting 24 hours after the administration of pemetrexed.
Arm group label:
Folinic acid arm
Summary:
Objective The main objective is to evaluate the haematological toxicity in patients who
use pemetrexed with and without rescue therapy with folinic acid.
Primary endpoint Difference between treatment groups in neutrophil count (*109/L) at day
8-10 after administration of pemetrexed (nadir).
Secondary endpoints The grade neutropenia (according to the CTCAE version 5, 2017) at day
8-10, the homocysteine plasma levels at baseline (predictor for developing toxicity), the
efficacy of chemotherapy treatment based on response CT after cycle 2 and 4 and the
incidence of discontinuation, dose delays and dose reductions of pemetrexed.
Trial design The FLEX-trial is a multi-centre, open label, double arm, randomized trial
to compare neutropenia in patients with and without folinic acid rescue therapy where
subjects are participating for 4 treatment cycles.
Population In total 50 patients (25 in each arm), >18 years with stage IV non-small cell
lung cancer (NSCLC) or mesothelioma treated with pemetrexed (in combination with other
chemo- or immunotherapy) are eligible for inclusion.
Interventions Follow-up will take place during the first 4 cycles of chemotherapy with
pemetrexed. Patients in the intervention-arm will receive oral folinic acid orally 4
times 45mg / day for 3 days, starting 24 hours after the administration of pemetrexed.
Criteria for eligibility:
Criteria:
In order to be eligible to participate in this study, a subject must meet all of the
following criteria:
1. ≥18 years old
2. Eligible for treatment with pemetrexed-based chemotherapy based on indication.
3. ECOG performance score of 0-2.
4. Subject is able and willing to sign the Informed Consent Form
A potential subject who meets any of the following criteria will be excluded from
participation in this study:
1. Contraindications for treatment with folinic acid in line with the SmPC.
1. Hypersensitivity to the active substance or to any of the excipients.
2. Anaemia caused by vitamin B12 deficiency.
2. The presence of clinically relevant drug-drug interactions, according to the current
SmPC of folinic acid.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amphia Hospital
Address:
City:
Breda
Zip:
4817
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Ramon Contrucci, MSc
Phone:
+31765954354
Email:
Rcontrucci@amphia.nl
Contact backup:
Last name:
Nikki de Rouw, Phd
Phone:
+31765957757
Email:
NdeRouw@amphia.nl
Facility:
Name:
Albert Schweitzer Hospital
Address:
City:
Dordrecht
Zip:
3318
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Ramon Contrucci, MSc
Phone:
+31765954354
Email:
RContrucci@amphia.nl
Contact backup:
Last name:
Charlotte van Kesteren, Phd
Email:
cvankesteren@asz.nl
Start date:
February 6, 2023
Completion date:
January 2024
Lead sponsor:
Agency:
Amphia Hospital
Agency class:
Other
Collaborator:
Agency:
Albert Schweitzer Hospital
Agency class:
Other
Source:
Amphia Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06010277
