Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02887651 : Cavity Boost Radiation Therapy vs. Observation in Cerebral Metastases After Complete Surgical Resection
PhasePhase 2/Phase 3
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- histologically confirmed metastasis of carcinoma (except small cell carcinoma) or
malignant melanoma

- 1-3 metastases in the preoperative MRI

- Karnofsky Performance Status (KPS) = 70

- Age > / = 18 years

- Recursive partitioning analysis (RPA) 1-2

- life expectation = 6 months

- no previous irradiation of the brain

- MRI examinations possible

- start of the radiation therapy possible within 6 month after surgery

- informed consent

Exclusion Criteria:

- confirmation of residual tumor in the postoperative MRI within 72 hours after surgery

- dementia or disease of central nervous system with a higher risk or radiogenic
toxicity

- contraindication for MRIs or lack of acceptance for a MRI

- Glasgow Coma Scale < 12

- Age < 18 years

- KPS < 70, RPA 3

- life expectation < 6 months

- therapeutic previous irradiation of the brain

- no histological confirmation of carcinoma metastases or malignant melanoma metastases

- cerebral metastases of small cell cancer, undifferentiate neuro-endocrine carcinoma,
lymphoma, leucemia, sarcoma or germ cell tumor

- leptomeningeal carcinosis

- distance of the cerebral metastasis to the optic system or radiation sensible brain
parts < 10 mm

- distance to further metastases < 3 cm

- metastases of the brain stem, Di- or Mesencephalons, Pons oder Medulla oblongata

- bone marrow dysfunction

- contrast agent allergy

- pregnancy

- no informed consent
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02887651      |      Link to official Clinicaltrials.gov listing
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