CancerGOATNCT02671994
Geriatric and Oncologic Assessment Before Treatment
A study testing G8 screening and Geriatric assessment in people with Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- G8 screening and Geriatric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Significance of Geriatric Assessment for Optimal Treatment of Older Cancer Patients
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.
- Conditions
- Cancer
- Being tested
- G8 screening, Geriatric assessment
- Keywords
- Geriatric Assessment, G8 screening, Oncologic treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G8 screeningOther
Geriatric assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: G8 screening; Other: Geriatric assessment |
| B (control group) | No intervention | Oncologic treatment decision based on standard assessment (ECOG Performance Status + clinical assessment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of planned oncologic treatment (number of participants, who complete the planned oncologic treatment)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sambavy Nadaraja, Odense University Hospital
- Investigators
- Jørn Herrstedt, MD, DMSc, Study director, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671994
- Sponsor's protocol ID
- GOAT
- Acronym
- GOAT
- Status last verified
- Jan 2019
- First submitted
- 27 Jan 2016
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 31279749
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Geriatric Assessment for Optimal Treatment of Older Cancer Patients
- ClinicalTrials.gov ID
- NCT02671994
- Acronym / sponsor ID
- GOAT / GOAT
- Conditions
- Cancer
- Keywords
- Geriatric Assessment, G8 screening, Oncologic treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (experimental group) | Experimental | Other: G8 screening, Other: Geriatric assessmentOncologic 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). |
| B (control group) | No intervention | –Oncologic treatment decision based on standard assessment (ECOG Performance Status + clinical assessment). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G8 screening | Other | A (experimental group) |
| Geriatric assessment | Other | A (experimental group) |
Primary outcome
Feasibility of planned oncologic treatment (number of participants, who complete the planned oncologic treatment)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 31279749Nadaraja 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørn Herrstedt, MD, DMSc study director
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G8 screening and Geriatric assessment in people with Cancer, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of planned oncologic treatment (number of participants, who complete the planned oncologic treatment) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02671994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.