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Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302) (PRAMECE-1302)

Primary Purpose

Neoplasm Metastases

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaire administration
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neoplasm Metastases focused on measuring brain metastases, Gamma Knife, Radiosurgery, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with newly diagnosed brain metastases
  • Patient with cancer regardless of the type of primary cancer, with anatomopathological proof
  • At least, one measurable lesion ≥ 10 mm on the MRI T1 gadolinium sequences
  • Number of brain metastases lower or equal to 5
  • Indication of radiosurgery treatment
  • Age ≥ 18 years old
  • ECOG-PS 0-2
  • Expected survival > 3 months
  • Ability to complete self-administered questionnaires. If the patient has a motor disability (hemibody deficit) that does not allow to complete himself the questionnaires, these will be read by a CRA of the Neurosurgery department who will outline the questions without making any comment.
  • A non-opposition form must have been completed by the patient

Exclusion Criteria:

  • Previous cancer (< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated
  • Previous brain radiotherapy
  • Neurological pathology with cognitive disorders existing before the study
  • Having a contraindication for MRI
  • Associated leptomeningeal disease
  • Patients having another severe or uncontrolled pathology which could compromise the participation at the study (such as infection, cardiovascular, digestive, renal or pulmonary disease)
  • Pregnant or breastfeeding woman. The women must not breastfeed for at least 6 months
  • Impossibility to submit to the medical examinations of the study due to geographic, social or mental reasons

Sites / Locations

  • CHRU de Lille - Hôpital Salengro

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

questionnaire administration

Arm Description

Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale)

Outcomes

Primary Outcome Measures

Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire
The 4 criteria are the perceived overall state, health, physical functioning, cognitive functioning and tiredness

Secondary Outcome Measures

Comparison of the scores obtained on the scales, questionnaires and Performance status at baseline and every 3 months (until 12 months) after Gamma Knife treatment
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life), Performance status (OMS)
Comparison of the scores obtained on the scales and questionnaires according to the type of primary cancer at baseline and every 3 months (until 12 months) after Gamma Knife treatment
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition)
Comparison of the scores obtained on different scales according to the type of associated treatments at baseline and every 3 months (until 12 months) after Gamma Knife treatment
The type of associated treatments are: chemotherapy, targeted therapy, corticoids, anti-epileptics, psychotropic drugs. The different scales are QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), ESAS (quality of life) and MoCA (cognition)
Correlation between the scores obtained on the different scales at the baseline and the progression-free survival / overall survival
Correlation between the scores obtained on the scales QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life) at baseline and those obtained at 3, 6, 9, 12 months
Correlation between the scores obtained on the scales during the study and the clinical neurological response at baseline and every 3 monts until 12 months after Gamma Knife treatment
The correlation will take into account the evolution of the systemic disease and the volumetric tumor response. Volumetric tumor responses will be calculated on the MRI's

Full Information

First Posted
May 19, 2015
Last Updated
October 19, 2018
Sponsor
Centre Oscar Lambret
Collaborators
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02565433
Brief Title
Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302)
Acronym
PRAMECE-1302
Official Title
Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.
Detailed Description
The patients who meet the selection criteria and who have accepted to participate at the study will answer different questionnaires of the study before radiosurgery and at 3, 6, 9 and 12 months after the treatment of brain metastases. Baseline examinations will be done before receiving the treatment during the hospitalisation for the Gamma Knife treatment, and then they will be repeated at the evaluation visits which are classically done every 3 months. MRI's will also be performed every 3 months. In this way, no additional travel or MRI will be carried out as part of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastases
Keywords
brain metastases, Gamma Knife, Radiosurgery, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
questionnaire administration
Arm Type
Experimental
Arm Description
Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale)
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Other Intervention Name(s)
survey administration
Intervention Description
Within 15 days before radiosurgery and then at 3, 6, 9, 12 months after radiosurgery, the patients who have accepted to participate will have to complete these questionnaires : QLQC30, BN20, IADL, HADS, MoCa, Edmonton Symptom Assessment Scale
Primary Outcome Measure Information:
Title
Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire
Description
The 4 criteria are the perceived overall state, health, physical functioning, cognitive functioning and tiredness
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Comparison of the scores obtained on the scales, questionnaires and Performance status at baseline and every 3 months (until 12 months) after Gamma Knife treatment
Description
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life), Performance status (OMS)
Time Frame
1 year
Title
Comparison of the scores obtained on the scales and questionnaires according to the type of primary cancer at baseline and every 3 months (until 12 months) after Gamma Knife treatment
Description
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition)
Time Frame
1 year
Title
Comparison of the scores obtained on different scales according to the type of associated treatments at baseline and every 3 months (until 12 months) after Gamma Knife treatment
Description
The type of associated treatments are: chemotherapy, targeted therapy, corticoids, anti-epileptics, psychotropic drugs. The different scales are QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), ESAS (quality of life) and MoCA (cognition)
Time Frame
1 year
Title
Correlation between the scores obtained on the different scales at the baseline and the progression-free survival / overall survival
Time Frame
1 year
Title
Correlation between the scores obtained on the scales QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life) at baseline and those obtained at 3, 6, 9, 12 months
Time Frame
1 year
Title
Correlation between the scores obtained on the scales during the study and the clinical neurological response at baseline and every 3 monts until 12 months after Gamma Knife treatment
Description
The correlation will take into account the evolution of the systemic disease and the volumetric tumor response. Volumetric tumor responses will be calculated on the MRI's
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with newly diagnosed brain metastases Patient with cancer regardless of the type of primary cancer, with anatomopathological proof At least, one measurable lesion ≥ 10 mm on the MRI T1 gadolinium sequences Number of brain metastases lower or equal to 5 Indication of radiosurgery treatment Age ≥ 18 years old ECOG-PS 0-2 Expected survival > 3 months Ability to complete self-administered questionnaires. If the patient has a motor disability (hemibody deficit) that does not allow to complete himself the questionnaires, these will be read by a CRA of the Neurosurgery department who will outline the questions without making any comment. A non-opposition form must have been completed by the patient Exclusion Criteria: Previous cancer (< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated Previous brain radiotherapy Neurological pathology with cognitive disorders existing before the study Having a contraindication for MRI Associated leptomeningeal disease Patients having another severe or uncontrolled pathology which could compromise the participation at the study (such as infection, cardiovascular, digestive, renal or pulmonary disease) Pregnant or breastfeeding woman. The women must not breastfeed for at least 6 months Impossibility to submit to the medical examinations of the study due to geographic, social or mental reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Le Rhun, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franck Bonnetain, MD
Organizational Affiliation
CHRU de Besançon
Official's Role
Study Director
Facility Information:
Facility Name
CHRU de Lille - Hôpital Salengro
City
Lille
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302)

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