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

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.

Eligibility

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Conditions3

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