Cyberknife auto-planning high-dose intensity SBRT trial

JRCT ID: jRCTs032230014

Registered date:10/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 12/02/2024
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Stereotactic body radiation therapy using Cyberknife, 18 Gy once a day, total dose 54 Gy, 3 times in total, total treatment period 3-5 days. The acceptable total treatment duration is 10 days. Treatment planning uses the provided automatic treatment planning template, with a prescribed dose of 54 Gy as a 60% isodose curve, matching PTV margins as much as possible, and ensuring that >95% of PTV is 54 Gy.

Outcome(s)

• Primary Outcome: 3-year local progression-free rate
• Secondary Outcome: Overall survival, progression-free survival, local progression-free survival, type of progression, early adverse event rate, late adverse event rate, serious adverse event rate, medical device failure

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Onishi Hiroshi
• Source(s) of Monetary Support: Accuray Japan K.K.