Evaluation of Repeated Whole Brain Radiotherapy Versus Best Supportive Care for Multiple Brain Metastases.
NCT ID: NCT03288272
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2016-04-30
2018-05-31
Brief Summary
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The current study protocol is aimed at evaluating primarily the toxicity as well as secondarily the local and loco-regional tumor control, overall survival and QoL after repeated WBRT using 2 different dose concepts (20 Gy in 10 Fx vs. 30 Gy in 15 Fx) compared to BSC.
Detailed Description
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Unfortunately, intracerebral recurrence happens. For example, in the cohort of Meyners et al.(2010) on WBRT in relatively radioresistant tumors, median time to recurrence was 4.5months and the local control rates at 6 and 12 months post radiationem were 37% and 15%, respectively. Furthermore, the treatment of intracerebral recurrence after previous WBRT is challenging. In case of \</= 3 recurrent BM, surgery or radiosurgery (RS) are options. One other option, especially in case of \>3 recurrent BM is repeated WBRT. In this setting, one of the first reports on repeated WBRT was published by Cooper et al. in 1990. The authors reported on repeated WBRT (n=52) consisting of 25 Gy in 10 fractions. Response to reirradiation was seen in 42% of the patients. Furthermore, the patients improved by at least one level in their neurologic function status. Survival after second therapy averaged 5 months. In the report by Wong et al. (1996) median dose of retreatment (n=86) was 20 Gy. Resolution of symptoms was achieved in 27% of patients, partial improvement in 43% and no improvement or worsening of symptoms was seen in 29% of patients. The majority of patients had no significant toxicity secondary to re-irradiation. Five patients had radiographic abnormalities of their brain consistent with radiation-related changes. One patient had symptoms of dementia that was thought to be caused by radiotherapy. Sadikov et al. (2007) reported on 72 patients who underwent repeated WBRT for recurrent or progressive BM. The median survival after re-irradiation was 4.1 months. One patient was reported as having memory impairment and pituitary insufficiency after 5 months of progression-free survival.
In the report by Mayer et al. on re-irradiation tolerance of the human brain -in this analysis focused on recurrent glioma-, the authors concluded that radiation-induced brain tissue necrosis is found to occur at normalized tolerance doses of cumulative \> 100 Gy.
The current study protocol is aimed at evaluating primarily the toxicity as well as secondarily the local and loco-regional tumor control, overall survival and QoL after repeated WBRT using 2 different dose concepts (20 Gy in 10 Fx vs. 30 Gy in 15 Fx) compared to BSC.
In the present trial, the primary endpoint toxicity as well as the secondary endpoints QoL, loco-regional progression-free survival, overall survival and imaging response in patients previously treated with WBRT requiring repeated WBRT for intracerebral tumor progression will be evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 - WBRT 10 x 2 Gy
Arm 1 - WBRT 10 x 2 Gy Whole brain radiotherapy with a total dose of 20 Gy in single fractions of 2 Gy
Whole Brain Radiotherapy
Radiotherapy of the whole brain
Arm 2 - WBRT 15 x 2 Gy
Arm 2 - WBRT 15 x 2 Gy Whole brain radiotherapy with a total dose of 30 Gy in single fractions of 2 Gy
Whole Brain Radiotherapy
Radiotherapy of the whole brain
Arm 3 - Best Supportive Care
Symptomatic treatment includes steroids, pain medication, nutritional support etc.
Best Supportive Care
Best Supportive Care including nutrition, pain medication, steroids as needed
Interventions
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Whole Brain Radiotherapy
Radiotherapy of the whole brain
Best Supportive Care
Best Supportive Care including nutrition, pain medication, steroids as needed
Eligibility Criteria
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Inclusion Criteria
* previous WBRT
* MR-imaging confirmed cerebral metastases (\>1)
* age ≥ 18 years of age
* Karnofsky Performance Score ³60
* For women with childbearing potential, (and men) adequate contraception.
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent (must be available before enrolment in the trial)
Exclusion Criteria
* Patients who have not yet recovered from acute high-grade toxicities of prior therapies
* Pregnant or lactating women
* Participation in another clinical study or observation period of competing trials, respectively
18 Years
ALL
No
Sponsors
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Stephanie Combs
OTHER
Responsible Party
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Stephanie Combs
Professor and Chair
Principal Investigators
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Stephanie E Combs, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Professor and Department Chair
Locations
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Technische Universität München (TUM), Klinikum rechts der Isar
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Scharp M, Hauswald H, Bischof M, Debus J, Combs SE. Re-irradiation in the treatment of patients with cerebral metastases of solid tumors: retrospective analysis. Radiat Oncol. 2014 Jan 3;9:4. doi: 10.1186/1748-717X-9-4.
Other Identifiers
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ERASER
Identifier Type: -
Identifier Source: org_study_id