Geriatric and Oncologic Assessment Before Treatment (GOAT)

January 2, 2019 updated by: Sambavy Nadaraja, Odense University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: G8 screening
Other: Geriatric assessment
No Intervention: B (control group)
Oncologic treatment decision based on standard assessment (ECOG Performance Status + clinical assessment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of planned oncologic treatment (number of participants, who complete the planned oncologic treatment)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Director: Jørn Herrstedt, MD, DMSc, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GOAT (CAGT/BCM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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