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A Phase II Study to Evaluate the Efficacy and Safety of Deep-Inspiration Breath-Hold Daily Adaptive Radiotherapy in Centrally Located Lung Tumors (PUDDING-STUDY)

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

Takashi Mizowaki

Kyoto University Hospital

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto

mizo@kuhp.kyoto-u.ac.jp

Kishi Noriko

Kyoto University Hospital

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto

+81-75-751-3762

kishin@kuhp.kyoto-u.ac.jp

Recruiting

Aug. 12, 2023

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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

Both

Primary lung tumor; Lung cancer; Metastatic lung tumor; Pulmonary metastasis; Oligometastasis

deep inspiration breath-hold adaptive radiotherapy

Primary lung tumor; Lung cancer; Metastatic lung tumor; Pulmonary metastasis; Oligometastasis

radiotherapy; deep inspiration breath-hold; adaptive radiotherapy

D008175

D011878; D062485

Treatment-related adverse events grade 3 or worse (CTCAE v5.0)

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

+81-75-753-4680

none