PET-guided Radiosurgery of Oligometastatic Cancer
- Conditions
- Oligometastasis wth two to five extracranial and not more than three ZNS lesions
- Registration Number
- DRKS00031316
- Lead Sponsor
- Städtisches Klinikum Dessau
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 198
ICD-10: C00-25, C30-34(NSCLC only), C37, C39, C44-45, C48, C50 (hormone-resistant only), C51-58, C60-61 (castration-resistant only), C63-69, C73-74, and C80
oligometastatic disease with =5 extracranial lesions and =3 intrecebral lesions wihtout presious treatment, after relapse after complete remission or partial remission
patient qualifies for cytotoxic systemic therapy
normal blood counts (Hb>8g/dl, ANC>1500/mm³, thrombocytes >100 000/mm³)
normal liver function tests (ASAT/ALAT/AP=2.5*ULN), if liver metastatic and to be treated: <5*ULN
Bilirubin <1,5*ULN
Creatinin clearance (Cockroft-Gault) > 50 ml/min
ability to understand research protocol and willing to comply with reassessments and follow-ups
consent to have the patient’s case re-discussed in interdisciplinary tumor boards.
negative pregnancy test for female patients aged <50 yrs.
if sexually active, ability to use pregnancy prevention methods until 12 months after ending chemotherapy.
male patients restrain from fostering a child until 12 months after last chemotherapy
Extragonadal germ cell tumor
Tumor or carcinoma with neuroendocrine features
Peritoneal carcinomatosis
Hormone-sensitive breast cancer
Hormone-sensitive prostate cancer
Sarcoma
Melanoma
Chorioncarcinoma
Hematooncological neoplasia
Chemotherapy within the last three months
Age = 18 yrs.
previous radiotherapy to at least one of the areas currently presenting with oligometastatic disease, exceptions are brain metastasis, and metastasis with compression of the spinal cord
pregnancy or lactation
patients not compliant with birth control measurements
previous or ongoing abuse of medical substances, drugs, or alcohol
non-compliance in respect of protocol requirements and follow-ups
uncontrolled physical or mental disabilities
-including instable angina
-cardiac ischemia within the last 3 months
-active/treated neurological/psychiatric diagnosis incl. dementia/seizures
- active, not controlled infectious disease or bacteremia
patients with a history of previous malignant disease, except successfully treated basal cell cancer of the skin or carcinoma-in-situ of the uterine cervix.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival
- Secondary Outcome Measures
Name Time Method overall survival<br>time to retreatment