DRKS00016613
Recruiting
Phase 1
eoadjuvant Radiotherapy (N-RT) for Intracerebal Metastases of Solid Tumors - NEPO_MUC
Klinik für Radioonkologie, Klinikum rechts der Isar, TU München0 sites48 target enrollmentJanuary 29, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- C79.3
- Sponsor
- Klinik für Radioonkologie, Klinikum rechts der Isar, TU München
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients meeting all of the following criteria will be considered for admission to the trial:
- •Patients with 1\-4 intracerebral metastases on contrast\-enhanced MRI from solid tumors with known histology confirmed
- •One brain metastasis is \= 3cm in size or
- •\-Persisting neurologic symptoms or symptomatic epilepsy from brain metastases despite treatment with steroids.
- •\-Tumor location close to eloquent brain areas therefore neurological symptoms can be expected without longtime steroidal medication.
- •\-Patient is deciding to undergo surgical intervention, if resection and radiation therapy are equal treatment options or if the patient declines radiation therapy.
- •Age \= 18 years of age
- •Karnofsky Performance Score \= 70, ECOG \= 1
- •For women with childbearing potential adequate contraception
- •Ability of subject to understand character and individual consequences of the clinical trial
Exclusion Criteria
- •Patients presenting with any of the following criteria will not be included in the trial:
- •Patients with unknown primary (CUP)
- •Tumor diameter of any single lesion exceeding 4 cm
- •Tumors causing severe neurological deficits or with mass effect requiring immediate surgical intervention
- •Previous radiotherapy to the brain
- •Known tumor of small cell histology, germ cell histology or lymphoma
- •Refusal of the patients to take part in the study
- •Patients who have not yet recovered from acute toxicities of prior therapies
- •Clinically active kidney\-liver or cardiac disease
- •Known carcinoma \< 5 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
Outcomes
Primary Outcomes
Not specified
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