PET-guided Radiosurgery of Oligometastatic Cancer - PETOC

Städtisches Klinikum Dessau0 个研究点目标入组 198 人开始时间: 2023年3月2日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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
•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.

发起方

Städtisches Klinikum Dessau