The effect of oral folinic acid rescue therapy on pemetrexed induced neutropenia and other toxicity: A randomized open-label trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502345-10-00

Enrollment

Registered

2023-01-18

Start date

2023-02-05

Completion date

2024-09-04

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesothelioma, Non small cell lung cancer (NSCLC), Thymoma

Brief summary

Difference in neutrophil count (*109/L) at day 8-10.

Detailed description

Grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10, Homocysteine plasma levels at baseline (μmol/L), Efficacy based on response CT after cycle 2 and 4 (categorical: response, partial response, progression), Incidence of discontinuation, dose delays and dose reductions.

Interventions

DRUGRescuvolin 15 mg

DRUGtabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Difference in neutrophil count (*109/L) at day 8-10.	—

Secondary

Measure	Time frame
Grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10, Homocysteine plasma levels at baseline (μmol/L), Efficacy based on response CT after cycle 2 and 4 (categorical: response, partial response, progression), Incidence of discontinuation, dose delays and dose reductions.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026