Geriatric Determinants of General Repercussion of Radiotherapy for Patient Over 75 Years With Prostate Cancer

NCT ID: NCT02876237

Last Updated: 2018-05-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-08-31

Brief Summary

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The investigators propose to carry out a prospective analysis of physical impact, psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of localized prostate cancer with an indication of curative radiotherapy. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities . The quality of life of patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the end of radiotherapy (2 months) and at 6 months. This short follow-up period seems appropriate in this elderly population and will allow an answer within 2 years to the problem raised in clinical practice.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

geriatric assessment and quality of life

Intervention Type OTHER

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.

Radiotherapy

Intervention Type RADIATION

standard radiotherapy

Interventions

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geriatric assessment and quality of life

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.

Intervention Type OTHER

Radiotherapy

standard radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Man with a histologically proven prostate cancer
2. Indication of a curative intent radiotherapy
3. Age ≥ 75 years
4. Patient who signed an informed consent

Exclusion Criteria

1. Patient with metastatic prostate cancer
2. Patient unable to submit to monitoring of the protocol for social, geographical or family reasons
3. A person who is not affiliated to a social security scheme or of such a scheme
4. Patient under trusteeship
Minimum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Cancerologie de l'Ouest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aurore GOINEAU, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancerologie de l'Ouest

Stéphane SUPIOT, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

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Institut de Cancérologie de l'Ouest

Angers, , France

Site Status

Hopital Henri Mondor

Créteil, , France

Site Status

Centre Georges François Leclerc

Dijon, , France

Site Status

CHD

La Roche-sur-Yon, , France

Site Status

Centre Hospitalier Bretagne Sud

Lorient, , France

Site Status

Centre Catherine de Sienne

Nantes, , France

Site Status

Clinique Armoricaine de Radiologie

Saint-Brieuc, , France

Site Status

CHP

Saint-Grégoire, , France

Site Status

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, , France

Site Status

Institut de Cancérologie de Loire

Saint-Priest-en-Jarez, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00300-47

Identifier Type: OTHER

Identifier Source: secondary_id

ICO-A-2014-04

Identifier Type: -

Identifier Source: org_study_id

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