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

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ClinicalTrials.gov Identifier: NCT02353000
Recruitment Status : Active, not recruiting
First Posted : February 2, 2015
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasm Metastasis Radiation: Stereotactic Radiosurgery Radiation: Whole Brain Radiotherapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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




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

  2. 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)

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

  4. 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

  5. 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:
  1. Brain salvage during follow-up [ Time Frame: 1 year ]
    Brain salvage during follow-up, type of salvage, and time to salvage after randomisation

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
Netherlands
VUmc
Amsterdam, Netherlands, 1081HV
AMC
Amsterdam, Netherlands, 1105AZ
Haaglanden MC
Den Haag, Netherlands, 2262BA
Maastricht Radiation Oncology (MAASTRO clinic)
Maastricht, Netherlands, 6202 AZ
Erasmus MC
Rotterdam, Netherlands, 3015CE
Instituut Verbeeten
Tilburg, Netherlands, 5042BS
ZRTI
Vlissingen, Netherlands, 4382EK
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Philippe Lambin, Prof. Dr. Maastro Clinic, The Netherlands

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT02353000     History of Changes
Other Study ID Numbers: 01-2015
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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