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

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase: Unknown; Phase 3

Conditions: Brain Metastases

Treatments: Radiation: stereotactic body radiotherapy (SBRT); Radiation: Whole-Brain Radiotherapy (WBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01535209

CAVITY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

SBRT to resection cavity

Experimental group

Description:

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

Treatment:

Radiation: stereotactic body radiotherapy (SBRT)

WBRT

Active Comparator group

Description:

30Gy in 10 fractions over 12 days to whole brain

Treatment:

Radiation: Whole-Brain Radiotherapy (WBRT)