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

This study is currently recruiting participants.
Verified January 2017 by Maastricht Radiation Oncology
Sponsor:
ClinicalTrials.gov Identifier:
NCT02353000
First Posted: February 2, 2015
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht Radiation Oncology
  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.

Condition Intervention
Neoplasm Metastasis Radiation: Stereotactic Radiosurgery Radiation: Whole Brain Radiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whole Brain Radiotherapy vs. Stereotactic Radiosurgery for 4 - 10 Brain Metastases:a Phase III Randomized Multicenter Trial

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Quality of life in patients with 4 - 10 brain metastases comparing WBRT and SRS [ Time Frame: Change in quality of life measured from baseline to 3 months after radiotherapy ]
    Quality of life is measured by the EQ-5D-5L, a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression)


Secondary Outcome Measures:
  • Overall survival steroid use (mg), toxicity including hair loss and fatigue. [ Time Frame: 1 year ]
    Overall survival

  • Time that patient is functioning independently (Karnofsky ≥ 70) [ Time Frame: Change in Karnofsky index from baseline to 3 months after radiotherapy ]
    Time that patient is functioning independently (Karnofsky ≥ 70)

  • Steroid use [ Time Frame: Change in steroid use from baseline to 3 months after radiotherapy ]
    Steroid use in mg over time

  • Toxicity measured by hair loss and fatigue [ Time Frame: Change in toxicity from baseline to 3 months after radiotherapy ]
    Toxicity measured by hair loss and fatigue using CTCAE version 4.0

  • Degree of independence [ Time Frame: Change in independence from baseline to 3 months after radiotherapy ]
    Degree of independence of patients using the Barthel index


Other Outcome Measures:
  • Brain salvage during follow-up [ Time Frame: 1 year ]
    Brain salvage during follow-up, type of salvage, and time to salvage after randomisation

  • Verbal learning [ Time Frame: Change in verbal recall and verbal recognition from baseline to 3 months after radiotherapy ]
    Verbal recall and verbal regognition is measured using the Hopkins Verbal Learning Test - Revised

  • Quality of life of cancer patients [ Time Frame: Change in Quality of life from baseline to 3 months after radiotherapy ]
    QoL will be measured using the EORTC QLQ-C30

  • Quality of life of cancer patients with brain neoplasms [ Time Frame: Change in Quality of life from baseline to 3 months after radiotherapy ]
    QoL will be measured using the EORTC QLQ-BN20

  • Quality of life of cancer patients measuring cancer-related fatigue [ Time Frame: Change in Quality of life from baseline to 3 months after radiotherapy ]
    QoL will be measured using the EORTC QLQ-FA13


Estimated Enrollment: 260
Study Start Date: July 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Radiosurgery
Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases:
Radiation: Stereotactic Radiosurgery
Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases
Whole Brain Radiotherapy
Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases:
Radiation: Whole Brain Radiotherapy
Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353000


Contacts
Contact: Jaap Zindler, MD 088-4455666 Jaap.zindler@maastro.nl
Contact: Philippe Lambin, Prof. Dr. 088-4455666 phillipe.lambin@maastro.nl

Locations
Netherlands
VUmc Recruiting
Amsterdam, Netherlands, 1081HV
Contact: Anna Bruynzeel, MD, Phd    +31204440436    ame.bruynzeel@vumc.nl   
AMC Recruiting
Amsterdam, Netherlands, 1105AZ
Contact: Edith Dieleman, MD    +31 20 566 34 33    e.m.dieleman@amc.uva.nl   
Haaglanden MC Recruiting
Den Haag, Netherlands, 2262BA
Contact: Ruud Wiggenraad, MD, Phd    +31 70 330 2071    r.wiggenraad@haaglandenmc.nl   
Contact: Ursula Fisscher    +31 70 330 2071    u.fisscher@haaglandenmc.nl   
Maastricht Radiation Oncology (MAASTRO clinic) Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Jaap Zindler, MD    088 44 55 591    jaap.zindler@maastro.nl   
Contact: Rody Zuidema    088 44 55 610    rody.zuidema@maastro.nl   
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015CE
Contact: Annemarie Swaak, MD    +31 10 70 41 347    a.swaak@erasmusmc.nl   
Instituut Verbeeten Not yet recruiting
Tilburg, Netherlands, 5042BS
Contact: Bing Oei, MD    +31 13 594 77 69    oei@bvi.nl   
ZRTI Not yet recruiting
Vlissingen, Netherlands, 4382EK
Contact: Lieneke van Veelen, MD, Phd    +31 88 42 70 000    l.vanveelen@zrti.nl   
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Philippe Lambin, Prof. Dr. Maastro Clinic, The Netherlands
  More Information

Publications:
Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT02353000     History of Changes
Other Study ID Numbers: 01-2015
First Submitted: January 16, 2015
First Posted: February 2, 2015
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes