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| Name | Class |
|---|---|
| Albert Schweitzer Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Folinic acid arm | Experimental | 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. |
|
| No folinic acid arm | No Intervention | Patients will be treated according to regular care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folinic acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in neutrophil count (*109/L) at day 8-10 after pemetrexed administration during 2 cycles of chemotherapy | To evaluate the haematological toxicity (continuous measure) in patients who use pemetrexed with and without rescue therapy with folinic acid. | Between day 8-10 in the first 2 cycles (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10 after pemetrexed administration during 2 cycles of chemotherapy | To evaluate the difference in haematological toxicity based on the CTCAE criteria for neutrophil count | Between day 8-10 in the first 2 cycles (each cycle is 21 days) |
| Homocysteine plasma levels at baseline (μmol/L) |
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In order to be eligible to participate in this study, a subject must meet all of the following criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Contraindications for treatment with folinic acid in line with the SmPC.
The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramon Contrucci, MSc | Contact | 0765954354 | rcontrucci@amphia.nl | |
| Nikki de Rouw, Phd | Contact | 0765957757 | nderouw@amphia.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphia Hospital | Recruiting | Breda | North Brabant | 4817 | Netherlands |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2023 | Aug 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
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To evaluate the influence of baseline homocysteine plasma levels on occurrence of haematological toxicity. |
| Once, before the start of the first cycle (each cycle is 21 days) |
| Efficacy based on response CT after cycle 2 and 4 (categorical: response, partial response, progression) | To evaluate the efficacy of the treatment with pemetrexed (based on CT-scan). | After the second and fourth cycle (each cycle is 21 days) |
| Incidence of discontinuation, dose delays and dose reductions of pemetrexed | To evaluate the incidence of treatment delay or dose reduction of pemetrexed. | 3 months |
| Albert Schweitzer Hospital | Not yet recruiting | Dordrecht | South Holland | 3318 | Netherlands |
|
| D018301 |
| Neoplasms, Mesothelial |
| D018193 | Neoplasms, Complex and Mixed |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |