Trial · NCT02234050

Trabectedin for Recurrent Grade II/III Meningioma

NCT02234050, Phase 2, Completed, European Organisation for Research and Treatment of Cancer - EORTC; results first posted 2025-07-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Trabectedin for Recurrent Grade II/III Meningioma. Trials, record NCT02234050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02234050

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trabectedin for Recurrent Grade II/III Meningioma
NCT number: NCT02234050
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Conditions: Recurrent High Grade Meningioma
Interventions: Trabectedin, Local standard of care
First posted: 2014-09-09
Last updated: 2025-07-10
Other registries' IDs: eudract:2014-002446-47
Results first posted: 2025-07-10

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS)	From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first up.PFS was assessed by its median the point time at which 50% of the patients have experienced disease progression or death.	Progression (PD) was measured according to the Macdonald response criteria as at least a 25% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) AND an absolute increase of ≥ 5 mm. Appearance of new lesions will also constitute PD (including lesions in previously unassessed areas). Progression Free Survival (PFS) was measured from the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. Patients without evidence of progression was censored at the last follow-up visit date. If a patient received a second anti-tumoral therapy without prior documentation of disease progression, the patient was censored at the date of starting new anti-tumoral therapy.
Secondary	Progression Free Survival at 6 Months (PFS-6)	From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. PFS at 6 months,the proportion of patients who have not experienced disease progression or death by 6 months is presented	The PFS probability at 6 months (PFS-6) was extracted from the Kaplan-Meyer PFS curve. 95% confidence intervals were computed based on the Greenwood's formula.
Secondary	Objective Response (CR/PR)	From the date of randomization until disease progression or death, up to 24 months from date of randomization.It was assessed every 9 or 12 weeks (see measure description for details).The response rate presented is based on the best response observed.	Tumor response was measured according to the Macdonald response criteria as Complete Response (CR): disappearance of all target and non-target lesions. Residual lesions (other than nodes \< 10 mm) thought to be non-malignant should be further investigated before CR can be accepted. Clinical evaluation must be stable or improving. No steroids should be needed. Partial Response (PR): at least a 50% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non target lesions must be non-PD. Clinical evaluation must be stable or improving. Steroid dose must be stable or diminishing. Objective response was defined as both CR and PR. It was scheduled every 9 weeks from randomization until progression and after discontinuation of treatment without progression, every 9 weeks for the first year from randomization and every 12 weeks thereafter.
Secondary	Overall Survival (OS)	From the date of randomization up to the date of death. OS was assessed by its median the point time at which 50% of the patients have experienced death.	Overall Survival (OS) was calculated from the date of randomization up to the date of death (any cause). For patients still alive or lost to follow-up at the time of analysis, survival will be censored at last follow-up visit date.
Secondary	Health-related Quality of Life (HRQol)	Baseline measurements were collected before or on the day of the start of protocol treatment, but no earlier than 28 days before. The median baseline Global health status / QoL scores per treatment arm is reported.	Due to the small sample size and low compliance in the Standard of Care (SoC) arm, the analysis of Quality of Life (QoL) was restricted to describing The Global health status / QoL scores at baseline. The Global health status / QoL scores are part of the EORTC QLQ-C30, which is a core questionnaire designed to assess the quality of life of cancer patients. These scores are derived from a specific scale within the EORTC Quality of Life Questionnaire (QLQ-C30) that evaluates the overall health status and quality of life of the patient. The scoring for the Global health status / QoL scale involves a linear transformation of the raw score to a standardized score ranging from 0 to 100. This scale is revised in version 3.0 of the QLQ-C30 and includes two items with a range of 6, specifically items 29 (Global health status)and 30 (QoL scale). Higher score values represent a better outcome i.e. a higher quality of life.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival (PFS)	From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first up.PFS was assessed by its median the point time at which 50% of the patients have experienced disease progression or death.	Per protocol population was defined as all patients who were eligible and had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy)	Months	MEDIAN
SECONDARY	Progression Free Survival at 6 Months (PFS-6)	From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. PFS at 6 months,the proportion of patients who have not experienced disease progression or death by 6 months is presented	Per protocol population: all patients who were eligible and had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy)	percentage of participants	NUMBER
SECONDARY	Objective Response (CR/PR)	From the date of randomization until disease progression or death, up to 24 months from date of randomization.It was assessed every 9 or 12 weeks (see measure description for details).The response rate presented is based on the best response observed.	Per protocol population: all patients who were eligible and had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy)	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	From the date of randomization up to the date of death. OS was assessed by its median the point time at which 50% of the patients have experienced death.	Per protocol population: all patients who were eligible and had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy)	Months	MEDIAN
SECONDARY	Health-related Quality of Life (HRQol)	Baseline measurements were collected before or on the day of the start of protocol treatment, but no earlier than 28 days before. The median baseline Global health status / QoL scores per treatment arm is reported.	Safety population: all patients who had started their allocated treatment (at least one dose of Trabectedin or start of local standard of care therapy). Additionally per protocol windows were used to allocate the Qol assessments to the baseline timepoint.	score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival (PFS)	Local Standard of Care	4.17	95% Confidence Interval 2.00 to 5.95	Months
Progression Free Survival (PFS)	Trabectedin	2.43	95% Confidence Interval 2.07 to 3.32	Months
Progression Free Survival at 6 Months (PFS-6)	Local Standard of Care	29.1	95% Confidence Interval 11.9 to 48.8	percentage of participants
Progression Free Survival at 6 Months (PFS-6)	Trabectedin	21.1	95% Confidence Interval 11.3 to 32.9	percentage of participants
Objective Response (CR/PR)	Local Standard of Care	0		percentage of participants
Objective Response (CR/PR)	Trabectedin	1.8		percentage of participants
Overall Survival (OS)	Local Standard of Care	10.61	95% Confidence Interval 5.91 to 13.54	Months
Overall Survival (OS)	Trabectedin	11.37	95% Confidence Interval 8.15 to 16.89	Months
Health-related Quality of Life (HRQol)	Local Standard of Care	54.2	Full Range 16.7 to 83.3	score on a scale
Health-related Quality of Life (HRQol)	Trabectedin	58.3	Full Range 0 to 100	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Trabectedin	61
Overall Study	STARTED	Local Standard of Care	29
Overall Study	COMPLETED	Trabectedin	0
Overall Study	COMPLETED	Local Standard of Care	4
Overall Study	NOT COMPLETED	Trabectedin	61
Overall Study	NOT COMPLETED	Local Standard of Care	25

Source ClinicalTrials.gov

Adverse events378

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Trabectedin	1	61
other	Anemia	Blood and lymphatic system disorders	Local Standard of Care	0	27
other	Febrile Neutropenia	Blood and lymphatic system disorders	Trabectedin	2	61
other	Febrile Neutropenia	Blood and lymphatic system disorders	Local Standard of Care	0	27
other	Other AE	Blood and lymphatic system disorders	Trabectedin	3	61
other	Other AE	Blood and lymphatic system disorders	Local Standard of Care	0	27
other	Myocarditis	Cardiac disorders	Trabectedin	1	61
other	Myocarditis	Cardiac disorders	Local Standard of Care	0	27
other	Sinus Tachycardia	Cardiac disorders	Trabectedin	1	61
other	Sinus Tachycardia	Cardiac disorders	Local Standard of Care	0	27

1 to 10 of 378Source ClinicalTrials.gov

See all 378 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Trabectedin	40	61
Total, all-cause mortality	Local Standard of Care	17	27
Total, other adverse events	Trabectedin	58	61
Total, other adverse events	Local Standard of Care	25	27
Total, serious adverse events	Trabectedin	26	61
Total, serious adverse events	Local Standard of Care	4	27

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27078728	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Trabectedin vs Local Standard of Care: deaths from any cause	Trial comparisons
Trabectedin vs Local Standard of Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02234050

GET https://conductscience.org/api/trials/v1/NCT02234050/events?page=2

API reference For AI assistants