Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection

Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01535209

Enrollment

100

Registered

2012-02-17

Start date

2012-01-31

Completion date

2014-12-31

Last updated

2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

Keywords

Stereotactic radiotherapy, Whole-brain radiotherapy, Resection cavity

Brief summary

Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.

Detailed description

Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.

Interventions

RADIATIONstereotactic body radiotherapy (SBRT)

18Gy in 1 fraction for resection cavity \<2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity \>4cm in maximum diameter

RADIATIONWhole-Brain Radiotherapy (WBRT)

10 x 3 Gy to whole brain

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with surgically removed histologically proven metastatic cancer * Subtotal or total resection of single brain metastasis * Presence of single brain metastasis in MRI * Karnofsky Performance Status ≥ 70 * Life expectancy \> 6 months (minimal extracranial disease or availability of effective oncology treatment) * No previous history of cranial irradiation * Availability of MRI * Starting radiotherapy within six weeks after neurosurgery * Negative pregnancy test for woman * Written informed consent

Exclusion criteria

* Dementia and central nervous system diseases leading to higher risk of radiation toxicity * Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI * Altered level of consciousness * Histologically proven metastatic small cell lung cancer

Design outcomes

Primary

Measure	Time frame	Description
Failure-free survival	5 months after radiotherapy	Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.

Secondary

Measure	Time frame	Description
Overall survival	2 years	—
Quality of life assessment	2 years	—
Time to distant intracranial progression	2 years	—
Time to local progression	2 years	Time to progression in the irradiated cavity

Countries

Poland

Contacts

Primary ContactWojciech Michalski, M.S.

W.Michalski@coi.waw.pl+48226433909

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026