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Unable to achieve accrural within anticipated timeframe
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiosurgery | Experimental | Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases: |
|
| Whole Brain Radiotherapy | Other | Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases: |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival steroid use (mg), toxicity including hair loss and fatigue. | Overall survival | 1 year |
| Time that patient is functioning independently (Karnofsky ≥ 70) | Time that patient is functioning independently (Karnofsky ≥ 70) |
| Measure | Description | Time Frame |
|---|---|---|
| Brain salvage during follow-up | Brain salvage during follow-up, type of salvage, and time to salvage after randomisation | 1 year |
| Verbal learning | Verbal recall and verbal regognition is measured using the Hopkins Verbal Learning Test - Revised |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Lambin, Prof. Dr. | Maastro Clinic, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VUmc | Amsterdam | 1081HV | Netherlands | |||
| AMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22217243 | Result | 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. | |
| 24621620 | 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. |
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| Whole Brain Radiotherapy | Radiation | Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases |
|
| Change in Karnofsky index from baseline to 3 months after radiotherapy |
| Steroid use | Steroid use in mg over time | Change in steroid use from baseline to 3 months after radiotherapy |
| Toxicity measured by hair loss and fatigue | Toxicity measured by hair loss and fatigue using CTCAE version 4.0 | Change in toxicity from baseline to 3 months after radiotherapy |
| Degree of independence | Degree of independence of patients using the Barthel index | Change in independence from baseline to 3 months after radiotherapy |
| Change in verbal recall and verbal recognition from baseline to 3 months after radiotherapy |
| Quality of life of cancer patients | QoL will be measured using the EORTC QLQ-C30 | Change in Quality of life from baseline to 3 months after radiotherapy |
| Quality of life of cancer patients with brain neoplasms | QoL will be measured using the EORTC QLQ-BN20 | Change in Quality of life from baseline to 3 months after radiotherapy |
| Quality of life of cancer patients measuring cancer-related fatigue | QoL will be measured using the EORTC QLQ-FA13 | Change in Quality of life from baseline to 3 months after radiotherapy |
| Amsterdam |
| 1105AZ |
| Netherlands |
| ZRTI | Flushing | 4382EK | Netherlands |
| Maastricht Radiation Oncology (MAASTRO clinic) | Maastricht | 6202 AZ | Netherlands |
| Erasmus MC | Rotterdam | 3015CE | Netherlands |
| Haaglanden MC | The Hague | 2262BA | Netherlands |
| Instituut Verbeeten | Tilburg | 5042BS | Netherlands |
| 23522151 | 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. |
| 23211715 | 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. |
| 34806396 | Derived | 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. |
| 28743240 | 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. |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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