Evaluation of Stereotactic Radiotherapy of the Resection Cavity after Surgery of Brain metastases compared to post-operative whole-brain radiotherapy.
Diese Studie befindet sich aktuell in der Nachbeobachtungsphase. Neue Patienten können nicht mehr aufgenommen werden. Eine Behandlung analog dieser Studie ist nach Indikationsstellung jedoch weiterhin möglich.
In advanced cancer disease brain metastases are common, difficult to treat, and are associated with a poor prognosis. As new local and systemic therapies are eventually resulting in improved survival and quality of life for patients with brain metastases, negative neurocognitive effects of radiation therapy are becoming increasingly important as well as good loco-regional disease control of brain metastases.
Concerning treatment, brain metastases remain a major clinical problem and a multidisciplinary approach to management should be adopted. Neurosurgical resection with postoperative whole brain radiotherapy (WBRT) is one major treatment option in solitary or symptomatic brain metastases. Furthermore, WBRT is recommended for multiple brain metastases. For a limited number of brain metastases stereotactic radiosurgery (SRS) has been established as a highly effective treatment alternative.
Recently, a new treatment approach combing neurosurgery with postoperative stereotactic radiotherapy (SRT) of the resection cavity is emerging. Based on available evidence, postoperative SRT of the resection cavity improves local control following surgery, reduces the number of patients who require whole brain radiotherapy, and is well tolerated (1).
This protocol is aimed at primarily evaluating the safety and toxicity profile of SRT to the resection cavity following neurosurgical resection combined with SRT of potentially further unresected brain metastases, compared to postoperative whole-brain radiotherapy (WBRT). Secondary, the local effect of SRT in patients with brain metastases will be assessed by measuring time to local recurrence (LR), local and loco-regional progression-free survival (PFS).
Additional systemic treatment will be carried out according to the standards of the National Center for Tumor Therapy (NCT).
- histologically confirmed solid cancer
- MRI confirmed cerebral metastases
- Neurosurgical resection of one cerebral metastasis
- age ≥ 18 years of age
- Karnofsky Performance Score ≥ 60
- for women with childbearing potential, (and men) adequate contraception.
- ability to understand character and individual consequences of the clinical trial written informed consent (must be available before enrolment in the trial)
- refusal of the patients to take part in the study
- previous radiotherapy to the brain
- 10 unresected brain metastases in postoperative MRI
- Patients who have not yet recovered from acute toxicities of prior therapies
- known carcinoma < 2 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- pregnant or lactating women