NCT02671994

Brief Summary

In a randomized controlled trial, the investigators wish to investigate, if oncologic treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT, if needed, in older frail patients with gynaecologic and urologic cancer is superior to standard assessment (PS and clinical assessment) in oncologic treatment decision.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.9 years

First QC Date

January 27, 2016

Last Update Submit

January 2, 2019

Conditions

Cancer

Keywords

Geriatric AssessmentG8 screeningOncologic treatment

Outcome Measures

Primary Outcomes (1)

  • Feasibility of planned oncologic treatment (number of participants, who complete the planned oncologic treatment)

    2 years

Study Arms (2)

A (experimental group)

EXPERIMENTAL

Oncologic treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT, if needed, in addition to standard assessment (ECOG Performance Status + clinical assessment).

Other: G8 screeningOther: Geriatric assessment

B (control group)

NO INTERVENTION

Oncologic treatment decision based on standard assessment (ECOG Performance Status + clinical assessment).

Interventions

G8 screeningOTHER
A (experimental group)
Geriatric assessmentOTHER
A (experimental group)

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histologically verified gynaecologic cancer (ovarian, uterine, or cervical cancer) or urologic cancer (prostate, bladder, or kidney cancer).
  • Suited for first line medical oncologic treatment with chemotherapy and/or targeted therapy.
  • Age ≥ 70 years.
  • Understands, speaks, and writes Danish.
  • Signed informed consent.

You may not qualify if:

  • Previous cancer diagnosis except for carcinoma in situ of the cervix or skin cancer other than malignant melanoma.
  • Previous chemotherapy and/or targeted therapy for current cancer diagnosis.
  • Previous radiation therapy or concomitant radiotherapy for current cancer diagnosis.
  • Surgery within the last 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • Nadaraja S, Matzen LE, Jorgensen TL, Dysager L, Knudsen AO, Jeppesen SS, Moller S, Herrstedt J; Academy of Geriatric Cancer Research (AgeCare). The impact of comprehensive geriatric assessment for optimal treatment of older patients with cancer: A randomized parallel-group clinical trial. J Geriatr Oncol. 2020 Apr;11(3):488-495. doi: 10.1016/j.jgo.2019.06.019. Epub 2019 Jul 3.

    PMID: 31279749DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Geriatric Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Jørn Herrstedt, MD, DMSc

    Odense University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 2, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

DK(1)