Folinic Acid for Prevention of Pemetrexed-induced Toxicity
- Registration Number
- NCT06010277
- Lead Sponsor
- Amphia Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Folinic acid arm Folinic acid 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.
- Primary Outcome Measures
Name Time Method Difference in neutrophil count (*109/L) at day 8-10 after pemetrexed administration during 2 cycles of chemotherapy Between day 8-10 in the first 2 cycles (each cycle is 21 days) To evaluate the haematological toxicity (continuous measure) in patients who use pemetrexed with and without rescue therapy with folinic acid.
- Secondary Outcome Measures
Name Time Method Grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10 after pemetrexed administration during 2 cycles of chemotherapy Between day 8-10 in the first 2 cycles (each cycle is 21 days) To evaluate the difference in haematological toxicity based on the CTCAE criteria for neutrophil count
Incidence of discontinuation, dose delays and dose reductions of pemetrexed 3 months To evaluate the incidence of treatment delay or dose reduction of pemetrexed.
Homocysteine plasma levels at baseline (μmol/L) Once, before the start of the first cycle (each cycle is 21 days) To evaluate the influence of baseline homocysteine plasma levels on occurrence of haematological toxicity.
Efficacy based on response CT after cycle 2 and 4 (categorical: response, partial response, progression) After the second and fourth cycle (each cycle is 21 days) To evaluate the efficacy of the treatment with pemetrexed (based on CT-scan).
Trial Locations
- Locations (2)
Amphia Hospital
🇳🇱Breda, Noord Brabant, Netherlands
Albert Schweitzer Hospital
🇳🇱Dordrecht, Zuid Holland, Netherlands