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 rate, disease-free survival rate, local recurrence-free survival rate, quality of life, grade 2 or more severe AEs, 1-year cumulative incidence of grade 2 or more severe radiation pneumonitis, the number of patients and fractions requiring adapted plans, data on dose-volume indices, structures of target volumes and OARs, set-up error, treatment time, quality assurance of planned online 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) Aged 20 years or older.
2) ECOG-PS of 0 or 1
3) Centrally located lung tumours with a maximum diameter of 5 cm or less, defined according to the IASLC recommendations as tumours located within 2 cm of the mediastinum (including bronchi, oesophagus, heart, brachial plexus, major blood vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve).
4) Patients who can hold their breath for more than 20 s.
5) Patients who are considered suitable for stereotactic body radiation therapy meet the predefined dose constraints for OARs, as determined by board-certified radiation oncologists.
6) Patients who provide written informed consent.

Exclude criteria

1) Patients with interstitial pneumonia
2) Life expectancy of less than 3 months according to estimations by board-certified radiation oncologists
3) Patients who are not capable of giving consent.

Related Information

• Primary Sponsor: Takashi Mizowaki