Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis

NCT04358666 | Unknown DMC

• 1 other identifier: 19-086
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion. second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol

Conditions

Quality of Life; Brain Metastases

Keywords

brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery

Outcome Measures

Primary Outcomes (1)

• quality of life EORTC QLQ C30

  score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30

  change between baseline and 6 month

Secondary Outcomes (5)

• local control of the desease

  baseline up to 24 month

• survival without progression

  24 month

• overall survival

  24 month

• medico economic evaluation

  24 month

• neuro cognitive evaluation

  12 and 24 month

Study Arms (2)

surgery and focal radiosurgery of the surgical site

ACTIVE COMPARATOR

Procedure: surgery and focal radiosurgery of the surgical bed

hypofractionned radiosurgery

ACTIVE COMPARATOR

Procedure: surgery and focal radiosurgery of the surgical bed

Interventions

surgery and focal radiosurgery of the surgical bed PROCEDURE

hypofractionned radiosurgery of the lesion

Also known as: hypofractionned radiosurgery of the lesion

hypofractionned radiosurgery; surgery and focal radiosurgery of the surgical site

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eligible for both treatments options OMS status \<3 primary cancer with no evolution brain metastasis \< 3cm ou giving symtoms patient with informed consent patient affilated to french social security

You may not qualify if:

• OMS \> 3 More than 3 brain metastasis brain metastasis already treated with hypofractionned radiosurgery

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU CAEN

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 24, 2020
• Study Start: March 6, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2024
• Last Updated: April 24, 2020

Record last verified: 2020-03

Locations

FR (1)