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

NCT02353000 | Terminated DMC

• 1 other identifier: 01-2015
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 7

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.

Conditions

Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• Quality of life in patients with 4 - 10 brain metastases comparing WBRT and SRS

  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)

  Change in quality of life measured from baseline to 3 months after radiotherapy

Secondary Outcomes (5)

• Overall survival steroid use (mg), toxicity including hair loss and fatigue.

  1 year

• Time that patient is functioning independently (Karnofsky ≥ 70)

  Change in Karnofsky index from baseline to 3 months after radiotherapy

• Steroid use

  Change in steroid use from baseline to 3 months after radiotherapy

• Toxicity measured by hair loss and fatigue

  Change in toxicity from baseline to 3 months after radiotherapy

• Degree of independence

  Change in independence from baseline to 3 months after radiotherapy

Other Outcomes (5)

• Brain salvage during follow-up

  1 year

• Verbal learning

  Change in verbal recall and verbal recognition from baseline to 3 months after radiotherapy

• Quality of life of cancer patients

  Change in Quality of life from baseline to 3 months after radiotherapy

Study Arms (2)

Stereotactic Radiosurgery

EXPERIMENTAL

Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases:

Radiation: Stereotactic Radiosurgery

Whole Brain Radiotherapy

OTHER

Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases:

Radiation: Whole Brain Radiotherapy

Interventions

Stereotactic Radiosurgery RADIATION

Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases

Stereotactic Radiosurgery

Whole Brain Radiotherapy RADIATION

Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases

Whole Brain Radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (7)

VUmc

Amsterdam, 1081HV, Netherlands

Location

AMC

Amsterdam, 1105AZ, Netherlands

Location

ZRTI

Flushing, 4382EK, Netherlands

Location

Maastricht Radiation Oncology (MAASTRO clinic)

Maastricht, 6202 AZ, Netherlands

Location

Erasmus MC

Rotterdam, 3015CE, Netherlands

Location

Haaglanden MC

The Hague, 2262BA, Netherlands

Location

Instituut Verbeeten

Tilburg, 5042BS, Netherlands

Location

Related Publications (6)

• Gijtenbeek JM, Ho VK, Heesters MA, Lagerwaard FJ, de Graeff A, Boogerd W. [Practice guideline 'Brain metastases' (revision)]. Ned Tijdschr Geneeskd. 2011;155(52):A4141. Dutch.

  PMID: 22217243 RESULT

• Yamamoto M, Serizawa T, Shuto T, Akabane A, Higuchi Y, Kawagishi J, Yamanaka K, Sato Y, Jokura H, Yomo S, Nagano O, Kenai H, Moriki A, Suzuki S, Kida Y, Iwai Y, Hayashi M, Onishi H, Gondo M, Sato M, Akimitsu T, Kubo K, Kikuchi Y, Shibasaki T, Goto T, Takanashi M, Mori Y, Takakura K, Saeki N, Kunieda E, Aoyama H, Momoshima S, Tsuchiya K. Stereotactic radiosurgery for patients with multiple brain metastases (JLGK0901): a multi-institutional prospective observational study. Lancet Oncol. 2014 Apr;15(4):387-95. doi: 10.1016/S1470-2045(14)70061-0. Epub 2014 Mar 10.

  PMID: 24621620 RESULT

• Zindler JD, Rodrigues G, Haasbeek CJ, De Haan PF, Meijer OW, Slotman BJ, Lagerwaard FJ. The clinical utility of prognostic scoring systems in patients with brain metastases treated with radiosurgery. Radiother Oncol. 2013 Mar;106(3):370-4. doi: 10.1016/j.radonc.2013.01.015. Epub 2013 Mar 20.

  PMID: 23522151 RESULT

• Langley RE, Stephens RJ, Nankivell M, Pugh C, Moore B, Navani N, Wilson P, Faivre-Finn C, Barton R, Parmar MK, Mulvenna PM; QUARTZ Investigators. Interim data from the Medical Research Council QUARTZ Trial: does whole brain radiotherapy affect the survival and quality of life of patients with brain metastases from non-small cell lung cancer? Clin Oncol (R Coll Radiol). 2013 Mar;25(3):e23-30. doi: 10.1016/j.clon.2012.11.002. Epub 2012 Dec 2.

  PMID: 23211715 RESULT

• Hartgerink D, Bruynzeel A, Eekers D, Swinnen A, Hurkmans C, Wiggenraad R, Swaak-Kragten A, Dieleman E, van der Toorn PP, van Veelen L, Verhoeff JJC, Lagerwaard F, de Ruysscher D, Lambin P, Zindler J. Quality of life among patients with 4 to 10 brain metastases after treatment with whole-brain radiotherapy vs. stereotactic radiotherapy: a phase III, randomized, Dutch multicenter trial. Ann Palliat Med. 2022 Apr;11(4):1197-1209. doi: 10.21037/apm-21-1545. Epub 2021 Nov 18.

  PMID: 34806396 DERIVED

• Zindler JD, Bruynzeel AME, Eekers DBP, Hurkmans CW, Swinnen A, Lambin P. Whole brain radiotherapy versus stereotactic radiosurgery for 4-10 brain metastases: a phase III randomised multicentre trial. BMC Cancer. 2017 Jul 25;17(1):500. doi: 10.1186/s12885-017-3494-z.

  PMID: 28743240 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe Lambin, Prof. Dr.

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 2, 2015
• Study Start: July 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (7)