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

NCT ID: NCT02565433

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-06-30

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.

Conditions

Neoplasm Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

questionnaire administration

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

Group Type: EXPERIMENTAL

questionnaire administration

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

survey administration

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Le Rhun, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Franck Bonnetain, MD

Role: STUDY_DIRECTOR

CHRU de Besançon

Locations

CHRU de Lille - Hôpital Salengro

Lille, , France

Countries

France

Other Identifiers

PRAMECE-1302

Identifier Type: -

Identifier Source: org_study_id