Geriatric and Oncologic Assessment Before Treatment

NCT ID: NCT02671994

Last Updated: 2019-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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A (experimental group)

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).

Group Type EXPERIMENTAL

G8 screening

Intervention Type OTHER

Geriatric assessment

Intervention Type OTHER

B (control group)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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G8 screening

Intervention Type OTHER

Geriatric assessment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sambavy Nadaraja

MD, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jørn Herrstedt, MD, DMSc

Role: STUDY_DIRECTOR

Odense University Hospital

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31279749 (View on PubMed)

Other Identifiers

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GOAT

Identifier Type: -

Identifier Source: org_study_id

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