- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02876237
Geriatric Determinants of General Repercussion of Radiotherapy for Patient Over 75 Years With Prostate Cancer (PROGERAD)
Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Angers, France, 49055
- Institut de Cancérologie de l'Ouest
-
Creteil, France, 94000
- Hôpital Henri Mondor
-
Dijon, France, 21079
- Centre Georges Francois Leclerc
-
La Roche Sur Yon, France, 85925
- CHD
-
Lorient, France, 56100
- Centre Hospitalier Bretagne Sud
-
Nantes, France, 44202
- Centre Catherine de Sienne
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St Brieuc, France, 22015
- Clinique Armoricaine de Radiologie
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St Gregoire, France, 35760
- CHP
-
St Nazaire, France, 44606
- Clinique Mutualiste de l'Estuaire
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St Priest En Jarez, France, 42270
- Institut de Cancérologie de Loire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Man with a histologically proven prostate cancer
- Indication of a curative intent radiotherapy
- Age ≥ 75 years
- Patient who signed an informed consent
Exclusion Criteria:
- Patient with metastatic prostate cancer
- Patient unable to submit to monitoring of the protocol for social, geographical or family reasons
- A person who is not affiliated to a social security scheme or of such a scheme
- Patient under trusteeship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: geriatric assessment and quality of life
Included patient must have a geriatric assessment before radiotherapy and 6 months later. Patient must complete quality of life questionnaire before radiotherapy then 2 and 6 months later. |
Included patient must have a geriatric assessment before radiotherapy and 6 months later. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities . Patient must complete quality of life questionnaire before radiotherapy then 2 and 6 months later.
standard radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire
Time Frame: 2 months
|
Tolerance will be called bad for the loss of 20 or more points (out of 100) between the initial assessment and evaluations at 2 and 6 months.
Tolerance will be called correct in other cases.
This threshold of 20 points was selected according to the work of Osoba.
|
2 months
|
Complete geriatric assessment
Time Frame: 6 months
|
This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .
|
6 months
|
General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire
Time Frame: 6 months
|
Tolerance will be called bad for the loss of 20 or more points (out of 100) between the initial assessment and evaluations at 2 and 6 months.
Tolerance will be called correct in other cases.
This threshold of 20 points was selected according to the work of Osoba.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: STEPHANE SUPIOT, MD, Institut de Cancérologie de l'Ouest
- Principal Investigator: Aurore GOINEAU, MD, Institut de Cancérologie de l'Ouest
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICO-A-2014-04
- 2014-A00300-47 (Other Identifier: French Health Products Safety Agency)
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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