High dose intensity stereotactic body radiotherapy (SBRT) with Cyberknife planned using treatment planning templates for medically inoperable stage I non-small cell lung cancer or small lung lesions clinically diagnosed as primary lung cancer: a multicenter prospective study.

Onishi Hiroshi0 个研究点目标入组 80 人开始时间: 2023年4月10日最近更新: 2024年1月22日

适应症

试验速览

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•(1)Those diagnosed with non-small cell lung cancer
•(2)Those diagnosed with c-Stage1
•(3)Those who do not have intrathoracic lesions judged to be highly likely to be cancer other than the primary tumor
•(4)Aged >=18 years, =<90 years at consent
•(5)ECOG Performance status of 0-2
•(6)Those who are judged to be inoperable, or those who are judged to be operable but refuse to undergo surgery.
•If one or more of the following (1) to (3) are met, the patient is judged to be inoperable.
•1 Performance status (ECOG) is 2-4.
•2 Have serious or poorly controlled heart disease.
•3 Diabetes that is poorly controlled even with continued use of insulin.
•(7)No history of radiation therapy to the chest
•(8)Those who meet the dose distribution and constraints limits
•(9)Those who meet the test values below
•1 WBC>=2,000 mm3
•2 Hb>=8.0 g dl
•3 PLT>=3.0 104 mm3
•4 T-bil=<3.0mg dl
•5 SpO2(room air)>=90
•(10)Those who meet the test values below
•1 FEV1.0>=700ml
•(11)Those who have obtained written consent from the patient

•(1)Those with active double cancer
•(2)Those with large cell neuroendocrine carcinoma.
•(3)Those with infections requiring systemic treatment
•(4)Those who have a fever of 38degrees Celsius or higher at the time of registration
•(5)Those with findings of interstitial pneumonia with a clear UIP pattern on CT
•(6)Those with a cough requiring narcotic drugs
•(7)Those who have psychosis and are judged to be difficult to participate in research.
•(8)Pregnant women, lactating women, women who may be pregnant, or those who do not intend to use contraception
•(9)Those who are judged inappropriate for inclusion in the study by a doctor

发起方

Onishi Hiroshi