Stereotactic radiotherapy for centrally and ultra-centrally located lung tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of stereotactic body radiotherapy (SBRT) for patients with centrally and ultra-centrally located lung tumors. It involves two groups: the STRICT-LUNG study focuses on centrally located tumors treated with standard-linacs, while the STAR-LUNG study targets ultra-centrally located tumors using MR-linacs. The study will assess treatment-related adverse events, local tumor control rates, and overall survival among participants. A total of 138 patients will be enrolled, with outcomes monitored over an extended period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histology or cytology proven non-hematological cancer or known cancer with local progressive recurrence.
* ECOG performance status ≤ 2.
* Age \> 18 years old. • Life expectancy \> 6 months.
* Maximum one central tumor with the diameter ≤ 5 cm or \> 1 adjacent located tumors with a summarized diameter (measured from the outer margin from one tumor to the outer margin of the other) of maximum 5 cm on a diagnostic CT-scan.
* Medically inoperable or refused surgery.
* The central tumors must be localized within or touching the 2.5 cm-zone of the PBT, or within 0.5 cm from the spinal cord, esophagus or heart. Evaluation is primarily performed on the diagnostic CT scan
* All metastatic sites are treated or planned for ablative therapy (including surgery). For oligo-progressive disease (OPD), only the sites in progression are required to fulfil this criterion
* Adequate lung function to tolerate treatment, at the discretion of the treating physician. • Ability to understand and willingness to sign a written informed consent document. • Patient must be accessible to treatment and follow-up procedures
* Fertile women must have a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use effective contraception for the duration of study treatment and one month thereafter.
* Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of the trachea, main bronchi or intermediate bronchus. Evaluation is primarily performed on the diagnostic CT scan
* Patients with other non-central tumors synchronous with the central lesion may be included and treated with SBRT in respect to local practice.
* A baseline PET/CT scan within 2 months of inclusion.
* An ablative strategy should be deemed clinically relevant and it is at the discretion of the treating physician to decide.

Exclusion Criteria:

* Tumor with intra-bronchial or intra-tracheal growth, as assessed on a diagnostic CT/MR-scan or endoscopic procedure
* If the patient has received previous radiotherapy, the combined dose at the radiation site must be evaluated by the treating physician and preferably not exceed the dose constraints
* Patient cannot tolerate the physical set up required for SBRT. • Uncontrolled intercurrent illness
* Pregnancy
* Patient participating in another interventional study
* For patients in STAR-LUNG, lack of MR compatibility due to pacemaker, inserted steel or similar.

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Herlev University Hospital
  Herlev, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Department of Oncology, Lillebaelt Hospital
  Vejle, Denmark Recruiting
• Aalborg University Hospital
  Aalborg, Denmark Not yet recruiting

Study contacts

• Study coordinator: Mette Pøhl, MD, PhD
• Email: mette.poehl@regionh.dk
• Phone: +4535451824

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.