Trial Outcomes & Findings for Variability of Definitions for Survival Endpoints and Surrogate Properties for OS in Sarcoma Trials: a Meta-analysis (NCT NCT02873923)

Results Overview

Number of deaths

Recruitment status

COMPLETED

Target enrollment

2846 participants

Primary outcome timeframe

up to 18 months following randomization

Results posted on

2021-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With a Metastatic Soft Tissue Sarcoma All patients included in eligible clinical trials of the meta-analysis
Overall Study STARTED	2846
Overall Study COMPLETED	2846
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Variability of Definitions for Survival Endpoints and Surrogate Properties for OS in Sarcoma Trials: a Meta-analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With a Metastatic Soft Tissue Sarcoma n=2846 Participants All patients included in eligible clinical trials of the meta-analysis
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2846 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	1423 Participants n=99 Participants
Sex: Female, Male Male	1423 Participants n=99 Participants

PRIMARY outcome

Timeframe: up to 18 months following randomization

Number of deaths

Outcome measures

Outcome measures
Measure	Patients With a Metastatic Soft Tissue Sarcoma n=2846 Participants All patients included in eligible clinical trials of the meta-analysis
Overall Survival	1704 Participants

SECONDARY outcome

Timeframe: Up to 12 months following randomization

Number of progressions or deaths. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Patients With a Metastatic Soft Tissue Sarcoma n=2846 Participants All patients included in eligible clinical trials of the meta-analysis
Progression-free Survival	2303 Participants

POST_HOC outcome

Timeframe: within 18 months following randomization

Individual-level association between 12-month progression-free survival and 18-month overall survival

Outcome measures

Outcome measures
Measure	Patients With a Metastatic Soft Tissue Sarcoma n=2846 Participants All patients included in eligible clinical trials of the meta-analysis
Individual-level Association	0.66 Correlation coefficient Interval 0.63 to 0.68

POST_HOC outcome

Timeframe: within 18 months following randomization

Trial-level association between 12-month progression-free survival and 18-month overall survival

Outcome measures

Outcome measures
Measure	Patients With a Metastatic Soft Tissue Sarcoma n=2846 Participants All patients included in eligible clinical trials of the meta-analysis
Trial-level Association	0.00 Correlation coefficient Interval 0.0 to 0.05

Adverse Events

Patients With a Metastatic Soft Tissue Sarcoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1704 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Carine Bellera

Institut Bergonié

Phone: 33 5 56 33 04 95

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place