IGRT
RadiationImage-Guided Radiation Therapy
NCT Number: NCT03561896
Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Canton Ticino, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Image-Guided Radiation Therapy
stereotactic radiation therapy
Time frame: 1 year
Evaluate the recurrence probability in the surgical cavity after radiotherapy
Time frame: 1 year
The proportion of surviving patients at 1 year
Time frame: 1 year
The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria
Time frame: 1 year
Time to neurological deterioration (objective neurological examination and MMSE)
Time frame: 1 year
Evaluation of the quality of life through questionnaire
Oncology Institute of Southern Switzerland
Other
Stereotactic Radiosurgery or Hypofractionated Image-Guided Radiotherapy to the Surgical Cavity After Resection of Brain Metastases: a Multicenter, Single Arm, Open-label, Phase II Trial
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