Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Geriatric and Oncologic Assessment Before Treatment (GOAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671994
Recruitment Status : Unknown
Verified January 2019 by Sambavy Nadaraja, Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sambavy Nadaraja, Odense University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cancer Other: G8 screening Other: Geriatric assessment Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Significance of Geriatric Assessment for Optimal Treatment of Older Cancer Patients
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Feasibility of planned oncologic treatment (number of participants, who complete the planned oncologic treatment) [ Time Frame: 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671994


Locations
Layout table for location information
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Layout table for investigator information
Study Director: Jørn Herrstedt, MD, DMSc Odense University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Sambavy Nadaraja, MD, PhD student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02671994    
Other Study ID Numbers: GOAT
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sambavy Nadaraja, Odense University Hospital:
Geriatric Assessment
G8 screening
Oncologic treatment