A Phase II stUdy to evaluate the efficacy and safety of deep-inspiration breath-hold Daily aDaptive radiotherapy In ceNtrally located lunG tumors

JRCT ID: jRCT1052230085

Registered date:12/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary lung tumor; Lung cancer; Metastatic lung tumor; Pulmonary metastasis; Oligometastasis
• Date of first enrollment: 06/10/2023
• Target sample size: 25
• Study type: Interventional
• Intervention(s): deep inspiration breath-hold adaptive radiotherapy

Outcome(s)

• Primary Outcome: Treatment-related adverse events grade 3 or worse (CTCAE v5.0)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Takashi Mizowaki