Skip to main content
Clinical Trials/NCT02876237
NCT02876237
Completed
Not Applicable

Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent

Institut Cancerologie de l'Ouest10 sites in 1 country230 target enrollmentFebruary 2015
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Institut Cancerologie de l'Ouest
Enrollment
230
Locations
10
Primary Endpoint
General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
August 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Institut Cancerologie de l'Ouest
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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 .

Study Sites (10)

Loading locations...

Similar Trials