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

NCT02876237 | Completed

• 2 other identifiers: ICO-A-2014-042014-A00300-47
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 10

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire

  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

  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

  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

Study Arms (1)

geriatric assessment and quality of life

EXPERIMENTAL

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.

Other: geriatric assessment and quality of life; Radiation: Radiotherapy

Interventions

geriatric assessment and quality of life 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.

geriatric assessment and quality of life

Radiotherapy RADIATION

standard radiotherapy

geriatric assessment and quality of life

Eligibility Criteria

• Age: 75 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Man with a histologically proven prostate cancer
• Indication of a curative intent radiotherapy
• Age ≥ 75 years
• Patient who signed an informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (10)

Institut de Cancérologie de l'Ouest

Angers, 49055, France

Location

Hopital Henri Mondor

Créteil, 94000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

CHD

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier Bretagne Sud

Lorient, 56100, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

Clinique Armoricaine de Radiologie

Saint-Brieuc, 22015, France

Location

CHP

Saint-Grégoire, 35760, France

Location

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, 44606, France

Location

Institut de Cancérologie de Loire

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Geriatric Assessment; Quality of Life; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Therapeutics

Study Officials

• Aurore GOINEAU, MD

  Institut de Cancerologie de l'Ouest

  PRINCIPAL INVESTIGATOR

• Stéphane SUPIOT, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: August 23, 2016
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

FR (10)