Fact CheckerSign in

NCT05237453Active, not recruiting

Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 9 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
13 Jan 2022
Start date
23 Jun 2022
Primary completion date
1 Mar 2027
Lead sponsor
University Hospital Heidelberg
Diseases
Lung cancer
NCT number
NCT05237453

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 23 Jun 2022 to the primary completion date, 1 Mar 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other

  • Involvement of supraclavicular lymph nodes (supraclavicular N3)
  • Additional pulmonary lesions (T3 - 4 due to additional lesion in the same or another lobe)
  • 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

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital of Heidelberg, Radiation Oncology
Coordinator of this site? Confirm its status
HeidelbergGermanyUnknown status
Ludwig-Maximilian-Universität München
Coordinator of this site? Confirm its status
MünichGermanyUnknown status
Universitätsklinikum Tübingen
Coordinator of this site? Confirm its status
TübingenGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.