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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)

uncontrolled control

single assignment

treatment purpose

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.

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.

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 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

+81-75-753-4680

July. 31, 2023

No

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