Stereotactic radiotherapy for centrally and ultra-centrally located lung tumors
Stereotactic Radiation Therapy In Centrally Located Lung and Ultra-centrally Located Tumors in the Lung. STRICT-LUNG & STAR-LUNG STUDY
This study is testing a type of targeted radiation therapy for patients with lung tumors located in tricky spots to see how safe and effective it is.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 6 sites (Aalborg and 5 other locations) |
| Trial ID | NCT05354596 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with centrally or ultra-centrally located lung tumors that are medically inoperable or for which surgery has been refused.
Not a fit: Patients with tumors invading critical structures like the trachea or heart may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with challenging lung tumors.
How similar studies have performed: Previous studies have shown promising results with stereotactic radiotherapy for lung tumors, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aalborg and 5 other locations
- Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
- 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)
Study contacts
- Study coordinator: Mette Pøhl, MD, PhD
- Email: mette.poehl@regionh.dk
- Phone: +4535451824
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.