Clinical trial · Interventional
Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302)
Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases
NCT02565433CI-TRIAL-00105595PRAMECEterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of recruitment
Summary
Brief summary (as posted)
The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- questionnaire administration
- description
- Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale)
- interventionNames
- Other: questionnaire administration
Primary outcomes (1)
- measure
- Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire
- timeFrame
- 6 months
- description
- The 4 criteria are the perceived overall state, health, physical functioning, cognitive functioning and tiredness
Secondary outcomes (6)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.