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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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052230085
Enrollment
25
Registered
2023-08-12
Start date
2023-10-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary lung tumor

Interventions

deep inspiration breath-hold adaptive radiotherapy
D062485
radiotherapy
deep inspiration breath-hold
adaptive radiotherapy

Sponsors

Takashi Mizowaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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/abdominal wall displacement

Contacts

Public ContactNoriko Kishi

Kyoto University Hospital

kishin@kuhp.kyoto-u.ac.jp+81-75-751-3762

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026