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Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases
Patients with limited number of brain metastases from solid tumors are at high risk of local recurrence after surgical removal of the tumor mass. The standard Whole-brain radiotherapy (WBRT) demonstrated to reduce the risk of recurrence without improving survival. At the same time WBRT have substantial acute and late toxicity. Preliminary experiences with Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity indicate promising local control and good tolerance. This attitude was only partially explored in prospective trials. In this research patients with limited number of brain metastases and controlled systemic disease will be treated, with such a stereotactic irradiation, at the same time with evaluation of the local control (Primary endpoint) by repeated MRI and of quality of life, neurologic functionning (with a battery of thsts, e.g. MMSE, QLQ-C30, EORTC BN-20) as well as overall survival as secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGRT | Experimental | Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity |
|
| SRS | Experimental | Stereotactic Radiosurgery of the resection cavity (SRS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGRT | Radiation | Image-Guided Radiation Therapy |
| |
| SRS |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate | Evaluate the recurrence probability in the surgical cavity after radiotherapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The proportion of surviving patients at 1 year | 1 year |
| Time to systemic progression | The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianfranco A Pesce, MD | IOSI, Bellinzona, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Southern Switzerland (IOSI) | Bellinzona | Canton Ticino | 6500 | Switzerland | ||
| Universitätsspital Basel |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Radiation |
stereotactic radiation therapy |
|
| 1 year |
| Time to neurological progression | Time to neurological deterioration (objective neurological examination and MMSE) | 1 year |
| Quality of life assessment | Evaluation of the quality of life through questionnaire | 1 year |
| Basel |
| 4031 |
| Switzerland |
| Inselspital | Bern | 3010 | Switzerland |
| Kantonsspital Winterthur | Winterthur | 8401 | Switzerland |
| Klinik Hirslanden | Zurich | 8032 | Switzerland |
| University Hospital Zurich (USZ) | Zurich | Switzerland |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |