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Cyberknife auto-planning high-dose intensity SBRT trial

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.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230014
Enrollment
80
Registered
2023-04-10
Start date
2024-02-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer non-small cell lung cancer

Interventions

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. Treatme

Sponsors

Onishi Hiroshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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, ==2,000 mm3 2 Hb>=8.0 g dl 3 PLT>=3.0 104 mm3 4 T-bil==90 (10)Those who meet the test values below 1 FEV1.0>=700ml (11)Those who have obtained written consent from the patient

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
3-year local progression-free rate

Secondary

MeasureTime frame
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

Contacts

Public ContactTakafumi Komiyama

University of Yamanashi Hospital

takafumi@yamanashi.ac.jp+81-55-273-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026