Trial Outcomes & Findings for Assessing Patient-reported & Patient-related Outcomes in Randomized Cancer Trials for Older Adults (NCT NCT03676218)

Last Updated: 2025-10-03

Results Overview

The domains were selected by the panel of experts based on the published guidelines (scientific societies, regulatory authorities, minimum datasets). Domains included functional autonomy, cognition, depression and nutrition. In addition, health-related quality of life, patients' symptoms, and satisfaction were also considered by the panel.

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

1 year after the consitution of the panel of experts

Results posted on

2025-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Involved in the Panel of International Experts Experts involved in the panel of experts for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for older patients with cancer No intervention: Panel of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Involved in the Panel of International Experts n=14 Participants Experts involved in the panel of experts for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for older patients with cancer No intervention: Panel of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
Age, Customized older than 18 years	14 Participants n=14 Participants
Sex: Female, Male Female	8 Participants n=14 Participants
Sex: Female, Male Male	6 Participants n=14 Participants
Region of Enrollment France	5 participants n=14 Participants
Region of Enrollment United Kingdom	1 participants n=14 Participants
Region of Enrollment Netherlands	1 participants n=14 Participants
Region of Enrollment Singapore	1 participants n=14 Participants
Region of Enrollment Belgium	2 participants n=14 Participants
Region of Enrollment United States	1 participants n=14 Participants
Region of Enrollment Italy	1 participants n=14 Participants
Region of Enrollment Norway	1 participants n=14 Participants
Region of Enrollment Canada	1 participants n=14 Participants

PRIMARY outcome

Timeframe: 1 year after the consitution of the panel of experts

Outcome measures

Outcome measures
Measure	Participants Involved in the Panel of International Experts n=14 Participants Experts involved in the panel of experts for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for older patients with cancer No intervention: Panel of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
Number of Domains Considered Relevant by the Panel of Experts When Assessing Treatment Efficacy in Randomized Cancer Trials for Older Patients With Cancer	7 geriatric domains

Adverse Events

Participants Involved in the Panel of International Experts

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carine Bellera, PhD

Institut Bergonié, Bordeaux Comprehensive Cancer Center

Phone: +33 5 56 33 04 95

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place