NCT02994914

Brief Summary

This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests) for elderly breast cancer patients. The score obtained at this evaluation will determine the radiotherapy scheme.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 5, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

3.6 years

First QC Date

September 21, 2016

Last Update Submit

February 4, 2022

Conditions

Breast Cancer

Keywords

Breast CancerOnco Geriatric EvaluationRadiotherapyHypo fractionated radiotherapyNormo fractionated radiotherapyLarge hypo fractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Measure of the tolerance

    Tolerance is considered as " bad " if the score of the onco geriatric evaluation decreases of more than 20% from the initial evaluation to 6 months after the end of the rays. Tolerance is considered as "correct" in the other cases.

    Month 6

Secondary Outcomes (8)

  • Tolerance

    Month 6

  • Quality of Life Questionnaire

    Month 6

  • Radiotherapy compliance

    Month 6

  • Correlation between tolerance and distance from the therapeutic center

    Month 6

  • Correlation between tolerance and way of transport

    Month 6

  • +3 more secondary outcomes

Study Arms (3)

Score of the Onco Geriatric Evaluation between 200 et 160

EXPERIMENTAL

According to the score obtained with the onco geriatric evaluation, patients with a score between 200 and 160 will receive a normo fractionated radiotherapy (66 Grays in 33 fractions). This scheme of radiotherapy is already used in the clinical practice, but not allocated according to a score obtained at an oncogeriatric evaluation.

Other: Onco Geriatric Evaluation

Score of the Onco Geriatric Evaluation between 159 et 120

EXPERIMENTAL

According to the score obtained with the onco geriatric evaluation, patients with a score between 159 and 120 will receive an hypo fractionated radiotherapy (42,56 Grays in 16 fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.

Other: Onco Geriatric Evaluation

Score of the Onco Geriatric Evaluation inferior to 119

EXPERIMENTAL

According to the score obtained with the onco geriatric evaluation, patients with a score inferior to 119 will receive a large hypo fractionated radiotherapy (30 Grays in 5 weekly fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.

Other: Onco Geriatric Evaluation

Interventions

Onco Geriatric EvaluationOTHER

Seven tests will be performed by an onco geriatrician : Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests. Those tests lead to a score, and this score will determine the scheme of patients radiotherapy.

Score of the Onco Geriatric Evaluation between 159 et 120Score of the Onco Geriatric Evaluation between 200 et 160Score of the Onco Geriatric Evaluation inferior to 119

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Woman more than 70 years old,
  • Patient carrying a breast cancer proven histologically and treated by radiotherapy in curative intent.

You may not qualify if:

  • Man,
  • Patient with metastatic cancer,
  • Patient with impossible follow-up at 6 months (planned relocation, patient support in another Center),
  • Patient under protection of justice or unable to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier Emile Roux

Le Puy-en-Velay, 43000, France

Location

Groupement Hospitalier Portes de Provence

Montélimar, 26216, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nicolas Magné, PhD

    Institut de Cancérologie Lucien Neuwirth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

December 16, 2016

Study Start

December 5, 2016

Primary Completion

June 26, 2020

Study Completion

June 26, 2020

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)