Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer
PUMA
1 other identifier
interventional
30
1 country
3
Brief Summary
MR-guided radiotherapy is an innovative technique which supports sophisticated approaches towards pulmonary adaptive radiotherapy (ART). Such individualized treatment approaches can lead to reduced toxicity and potentially better local tumor control for patients with LA-NSCLC in the future. PUMA is an early clinical trial, which aims to demonstrate the feasibility of MR-guided online ART to locally-advanced NSCLC. In a second step, the investigators aim to use the data from this feasibility trial to design and launch a further phase I/II clinical study that directly compares the benefits of MR-guided online ART of LA-NSCLC to CT-based (A)RT approaches.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable nonsmall-cell-lung-cancer
Started Jun 2022
Longer than P75 for not_applicable nonsmall-cell-lung-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
June 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
March 9, 2026
March 1, 2026
4.7 years
January 13, 2022
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
clinical feasibility -1-
successfully completed online adapted RT fractions
through study completion, an average of 2 years
clinical feasibility -2-
treatment time for online adapted RT fractions
through study completion, an average of 2 years
Secondary Outcomes (7)
acute side effects
3 months from treatment start
subacute side effect
6 months from treatment start
chronic side effect
through study completion, at least 24 months
Local tumor control
through study completion, at least 24 months
Progession free survival
through study completion, at least 24 months
- +2 more secondary outcomes
Study Arms (1)
MR-guided adaptive radiotherapy
EXPERIMENTALPatients receive Photon radiotheray as an MR-guided adaptive radiotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Histologically-proven non-small cell lung cancer (NSCLC)
- Stage III A - C according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification
- Indication for definitive thoracic chemoradiotherapy
- Age ≥ 18 years
- ECOG 0 - 2
- Adequate pulmonary function for chemoradiotherapy confirmed by a current pulmonary function test (≤ 6 weeks from treatment start)
- Ability to lie still on the MR-linac table for at least one hour
- Ability to hold one's breath for at least 20 seconds
- Successful completion of an MR-guided treatment simulation
- For women with childbearing potential: adequate contraception
- Ability of the patient to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
You may not qualify if:
- Involvement of supraclavicular lymph nodes (supraclavicular N3)
- Additional pulmonary lesions (T3 - 4 due to additional lesion in the same or another lobe)
- Previous radiotherapy of the lung and mediastinum, if previous and current target volumes overlap
- Patients who have not yet recovered from acute toxicities of prior therapies
- Contraindications against performing MRI scans (e.g. pacemakers or other implants making MRI impossible)
- Pregnant or lactating women
- Participation in another competing clinical study or observation period of competing trials
- Refusal of the patients to take part in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Tuebingencollaborator
- University Hospital Heidelberglead
- Ludwig-Maximilians - University of Munichcollaborator
- German Cancer Research Centercollaborator
Study Sites (3)
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Ludwig-Maximilian-Universität München
Münich, Bavaria, 81377, Germany
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120, Germany
Related Publications (1)
Regnery S, de Colle C, Eze C, Corradini S, Thieke C, Sedlaczek O, Schlemmer HP, Dinkel J, Seith F, Kopp-Schneider A, Gillmann C, Renkamp CK, Landry G, Thorwarth D, Zips D, Belka C, Jakel O, Debus J, Horner-Rieber J. Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced: the PUMA trial. Radiat Oncol. 2023 May 4;18(1):74. doi: 10.1186/s13014-023-02258-9.
PMID: 37143154DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juergen Debus, Prof
University Hospital Heidelberg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
January 13, 2022
First Posted
February 14, 2022
Study Start
June 23, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share