A Multicenter Phase II Study of Stereotactic Radiotherapy for Centrally Located Lung Tumors (STRICT-LUNG STUDY) and Ultra-centrally Located Lung Tumors (STAR-LUNG STUDY).
NCT ID: NCT05354596
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2022-11-01
2033-05-01
Brief Summary
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Detailed Description
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The tumor is considered central when the tumor is located within 0.5 -2.5 cm in all directions of the PBT or the esophagus. The PBT includes trachea, main bronchi and intermediate bronchus and 5 lobar bronchi. In addition, the tumor is also considered central, if it is located \<0.5 cm from the spinal cord, heart and aorta.
Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of trachea, main bronchi or intermediate bronchus. The patient will be excluded if the tumor invades the trachea, bronchi, esophagus, or pericardium/heart (radiological or by bronchoscopy assessment).
The main purposes are to evaluate the feasibility, safety and efficacy of stereotactic radiation to centrally and ultra-centrally located tumors, including treatment related adverse events, quality of life (QoL) assessments, local tumor control rate, disease free survival, and overall survival and facilitate future stratification of this patient group for definitive treatment.
Treatment related adverse events (TRAE) will be registered at baseline, end of treatment, 4-6 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60 months after treatment, and hereafter every year until 10th year of follow-up.
Enrolment in both trial categories may continue until the required numbers in both groups have been reached.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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STRICT LUNG
Central Tumors in the Lung The tumor is considered central when the tumor is located within 0.5 -2.5 cm in all directions of the PBT or the esophagus. The PBT includes trachea, main bronchi and intermediate bronchus and 5 lobar bronchi. In addition, the tumor is also considered central, if it is located \<0.5 cm from the spinal cord, heart and aorta.
STRICT LUNG
Stereotactic body radiation therapy: Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation.
STAR LUNG
Ultra-Centrally Tumors in the Lung Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of trachea, main bronchi or intermediate bronchus. The patient will be excluded if the tumor invades the trachea, bronchi, esophagus, or pericardium/heart (radiological or by bronchoscopy assessment).
STAR LUNG
Stereotactic body radiation therapy: Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.
Interventions
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STRICT LUNG
Stereotactic body radiation therapy: Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation.
STAR LUNG
Stereotactic body radiation therapy: Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Odense University Hospital
OTHER
Vejle Hospital
OTHER
University of Copenhagen
OTHER
Aalborg University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Mette Pøhl
MD PhD
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev University Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Department of Oncology, Lillebaelt Hospital
Vejle, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Rasmus Kjeldsen, MD
Role: primary
Wiviann Ottosson, MSc
Role: backup
Tine Bj Nielsen, MSc, PhD
Role: backup
Rune S Thing, MSc
Role: backup
References
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Hoffmann L, Persson GF, Nygard L, Nielsen TB, Borrisova S, Gaard-Petersen F, Josipovic M, Khalil AA, Kjeldsen R, Knap MM, Kristiansen C, Moller DS, Ottosson W, Sand H, Thing R, Pohl M, Schytte T. Thorough design and pre-trial quality assurance (QA) decrease dosimetric impact of delineation and dose planning variability in the STRICTLUNG and STARLUNG trials for stereotactic body radiotherapy (SBRT) of central and ultra-central lung tumours. Radiother Oncol. 2022 Jun;171:53-61. doi: 10.1016/j.radonc.2022.04.005. Epub 2022 Apr 11.
Other Identifiers
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H-21041667
Identifier Type: -
Identifier Source: org_study_id
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