A Phase II stUdy to evaluate the efficacy and safety of deep-inspiration breath-hold Daily aDaptive radiotherapy In ceNtrally located lunG tumors
- Conditions
- Primary lung tumorLung cancerMetastatic lung tumorPulmonary metastasisOligometastasisD008175
- Registration Number
- JPRN-jRCT1052230085
- Lead Sponsor
- Takashi Mizowaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
1) Patients aged 20 years or older
2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3) Central lung tumors 5 cm or less (central lung tumor is defined according to IASLC recommendations: located 2 cm or less from mediastinum, including bronchus, esophagus, heart, brachial plexus, vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve)
4) Ability to hold breath for at least 20 seconds
5) Indicated for stereotactic body radiotherapy or hypofractionated radiotherapy by a radiation oncologist.
6) Written informed consent to participate in the study is obtained
1) Patients with interstitial pneumonia
2) who are not expected to live 3 months or longer, according to the physician
3) who are unable to consent to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment-related adverse events grade 3 or worse (CTCAE v5.0)
- Secondary Outcome Measures
Name Time Method Overall survival, progression-free survival, local progression-free survival, Quality of Life, treatment-related adverse events grade 2 or worse, the 1-year cumulative incidence of radiation pneumonitis grade 2 or worse, dose-volume indices, structures of target volumes and organs at risk, set-up error, treatment time, quality assurance of planned adaptive radiotherapy treatment, medical images, and ventilation volume