Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lower Silesian Oncology Center | UNKNOWN |
| Copernicus Memorial Hospital | OTHER |
| Prof. Franciszek Lukaszczyk Memorial Oncology Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT to resection cavity | Experimental | 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 |
|
| WBRT | Active Comparator | 30Gy in 10 fractions over 12 days to whole brain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiotherapy (SBRT) | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival | Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death. | 5 months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 years | |
| Quality of life assessment | 2 years | |
| Time to distant intracranial progression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wojciech Michalski, M.S. | Contact | +48226433909 | W.Michalski@coi.waw.pl |
| Name | Affiliation | Role |
|---|---|---|
| Lucyna Kepka, Prof. | M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.Sklodowska-Curie Memorial Cancer Centre | Recruiting | Warsaw | 02-781 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Whole-Brain Radiotherapy (WBRT) | Radiation | 10 x 3 Gy to whole brain |
|
|
| 2 years |
| Time to local progression | Time to progression in the irradiated cavity | 2 years |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided