"Regina Elena" National Cancer Institute
Rome, 00144, Italy
Location status: Recruiting
NCT Number: NCT06992973
In this study, the possibility of performing a preoperative neoadjuvant radiotherapy dose of 27 Gy fractionated in 3 sessions is explored, to maximize the biological effect of the treatment, in patients affected by solid tumors, in particular lung, breast and melanoma, in which brain metastases have arisen, the incidence of which is constantly increasing in relation to the improvements in oncological therapies and the consequent increase in patient survival. It was demonstrated that postoperative stereotactic radiosurgery with this fractionation was effective in improving local disease control at 1 year compared to single-dose stereotactic radiosurgery (91% vs 77%) and in reducing the risk of radionecrosis for metastatic brain lesions of size.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rome, 00144, Italy
Location status: Recruiting
The treatment of potentially resectable brain metastases in association with preoperative fractionated stereotactic radiotherapy (FSRT) involves the administration of radiation therapy to an intact lesion, with the advantage of presenting fewer uncertainties in terms of target definition and does not require the addition of additional irradiation margins.
Furthermore, the reduction of the dose to healthy brain tissue may lead to a lower risk of inducing subsequent radionecrosis. In fact, the volume of healthy brain tissue irradiated is a recognized predictive factor for the induction of radionecrosis. The overall reduction of treatment times (FSRT + Surgery) with higher compliance by patients and improved logistics. Furthermore, potential advantages consist in the fact that a neoadjuvant radiosurgical treatment can potentially prevent cells scattered during surgery from causing neoplastic leptomeningitis, as these would have already received ablative irradiation. That radiation treatment on a target with an intact vascular supply is potentially more effective because the irradiation bed after surgery is more hypoxic.
It has been observed that over 20% of patients undergoing surgical resection of a metastasis do not undergo the planned radiosurgery due to complications, disease progression or other reasons for delay. The treatment therefore offers the possibility of delivering a higher biological dose with a greater probability of local control and a lower risk of meningeal spread and symptomatic radionecrosis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment based on stereotactic radiosurgery fractionated within 48-72, followed by surgery for symptomatic brain lesions, amenable to surgical treatment, associated or not with a maximum of 3 additional smaller metastatic brain lesions. The dose will be 27 Gy in three fractions (9 Gy per fraction) on alternate days.
If other lesions are present, up to a maximum of 3 lesions and a total volume of 35 cc, these will be treated with radical stereotactic radiosurgery according to guidelines.
Time frame: 24 months
To evaluate the efficacy of treatment based on Fractionated Stereotactic Radiosurgery followed (within 48-72 h) by Surgery for symptomatic brain lesions (susceptible to surgical treatment) associated or not with a maximum of 3 additional smaller brain metastatic lesions (susceptible to radiosurgical treatment). Local control of the disease after 24 months from treatment by carrying out all the evaluations and analyses that are part of the clinical management of this type of patient and required by the planned radio-surgical treatment.
Contact information is provided by the study sponsor or research team.
Regina Elena Cancer Institute
Other
Prospective Clinical Study on the Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06857006
Brain Diseases, Brain Metastases
Birmingham, Alabama, United States
View Trial DetailsNCT05692635
Brain Diseases, Brain Metastases
Winston-Salem, North Carolina, United States
View Trial DetailsNCT05673928
Brain Diseases, Brain Metastases
Houston, Texas, United States
View Trial DetailsNCT02390518
Brain Diseases, Brain Metastases
Salt Lake City, Utah, United States
View Trial Details