Neoplasm Metastases Clinical Trial
— PRAMECE-1302Official title:
Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases
NCT number | NCT02565433 |
Other study ID # | PRAMECE-1302 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2013 |
Est. completion date | June 2018 |
Verified date | October 2018 |
Source | Centre Oscar Lambret |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.
Status | Terminated |
Enrollment | 52 |
Est. completion date | June 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Lille - Hôpital Salengro | Lille |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret | Centre Hospitalier Universitaire de Besancon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 months | |
Secondary | 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) | 1 year | |
Secondary | 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) | 1 year | |
Secondary | 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) |
1 year | |
Secondary | Correlation between the scores obtained on the different scales at the baseline and the progression-free survival / overall survival | 1 year | ||
Secondary | 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 | 1 year | ||
Secondary | 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 | 1 year |
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