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

Neoplasm Metastases Clinical Trial

— PRAMECE-1302  

Official title:

Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02565433
• Other study ID #: PRAMECE-1302
• Status: Terminated
• Phase: N/A
• Start date: November 2013
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Neoplasm Metastases
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Other:
• questionnaire administration
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

Locations

Country	Name	City	State
France	CHRU de Lille - Hôpital Salengro	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

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