Whole Brain Radiotherapy (WBRT) Versus Stereotactic Radiosurgery (SRS) for 4 Upto 10 Brain Metastases

Study Purpose

Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the gold standard for patients with more than 3 brain metastases, but has significant side effects. In this prospective randomized phase III trial WBRT is compared to SRS for patients with 4 up to 10 BM.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Minimal 4 up to a maximum of 10 BM on diagnostic MRI scan - Max diameter of single GTV 2.5cm - Max cumulative GTV of 30cm3 - Karnofsky performance status ≥ 70 - Any solid primary tumour.
Small cell lung carcinoma, germinoma, and lymphoma are excluded - Ability to provide written informed consent

Exclusion Criteria:

- Contra-indication for MRI - Prior treatment for BM (i.e. surgery, SRS or WBRT) - Concurrent use of systemic therapy - Maximum cumulative GTV of more than 30cm3 on planning-MRI - More than 10 BM on planning-MRI - A brainstem metastasis with a PTV of more than 20 cm3

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02353000
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Maastricht Radiation Oncology
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Philippe Lambin, Prof. Dr.
Principal Investigator Affiliation Maastro Clinic, The Netherlands
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neoplasm Metastasis
Additional Details

Dutch guideline advices stereotactic radiosurgery (SRS) for patients with 1 up to 3 brain metastases (BM) and whole brain radiotherapy (WBRT) for patients with 4 or more BM. The interim analysis from the QUARTZ study showed that WBRT did not provide benefit in quality of life nor survival over best supportive care. WBRT has significant side effects, such as hair loss, fatigue, and cognitive dysfunction which may impair quality of life. A recently published study showed that SRS in patients with 5 up to 10 BM had a comparable survival to patients treated with 2 up to 4 BM. Many systemic therapies do not have a satisfactory intracranial response, because of the blood-brain barrier. The potential advantages of SRS i.e, limiting radiation doses to the uninvolved brain and a high rate of local tumour control by just a single treatment. Next logic step would be to compare WBRT with SRS alone in patients with 4-10 BM and evaluate whether SRS is superior to WBRT with regard to QOL.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

VUmc, Amsterdam, Netherlands

Status

Recruiting

Address

VUmc

Amsterdam, , 1081HV

Site Contact

Anna Bruynzeel, MD, Phd

ame.bruynzeel@vumc.nl

+31204440436

AMC, Amsterdam, Netherlands

Status

Recruiting

Address

AMC

Amsterdam, , 1105AZ

Site Contact

Edith Dieleman, MD

e.m.dieleman@amc.uva.nl

+31 20 566 34 33

Haaglanden MC, Den Haag, Netherlands

Status

Recruiting

Address

Haaglanden MC

Den Haag, , 2262BA

Site Contact

Ruud Wiggenraad, MD, Phd

r.wiggenraad@haaglandenmc.nl

+31 70 330 2071

Maastricht, Netherlands

Status

Recruiting

Address

Maastricht Radiation Oncology (MAASTRO clinic)

Maastricht, , 6202 AZ

Site Contact

Jaap Zindler, MD

jaap.zindler@maastro.nl

088 44 55 591

Erasmus MC, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus MC

Rotterdam, , 3015CE

Site Contact

Annemarie Swaak, MD

a.swaak@erasmusmc.nl

+31 10 70 41 347

Instituut Verbeeten, Tilburg, Netherlands

Status

Not yet recruiting

Address

Instituut Verbeeten

Tilburg, , 5042BS

Site Contact

Bing Oei, MD

oei@bvi.nl

+31 13 594 77 69

ZRTI, Vlissingen, Netherlands

Status

Not yet recruiting

Address

ZRTI

Vlissingen, , 4382EK

Site Contact

Lieneke van Veelen, MD, Phd

l.vanveelen@zrti.nl

+31 88 42 70 000

Stay Informed & Connected