Short summary

An open-label phase II study, investigating toxicity, treatment efficacy and the local tumor control rate in 69 patients with centrally located tumors and in 69 patients with ultra-centrally located tumors in the lung. Treatment and patient outcomes will be recorded. Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation. Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation

Rationale

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. The STRICT-LUNG study will evaluate the feasibility and safety of daily image-guided SBRT in centrally located lung tumors (primary, oligo-metastatic, or oligo-progressive). The STAR-LUNG study will evaluate the feasibility and safety of daily adaptive MR-linac based SBRT in ultra-centrally located lung tumors (primary, oligo-metastatic, or oligo-progressive). 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.

Description of the cohort

Non operable patients with solid carcinomas located centrally or Ultra-centrally 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). 6 Oncological Departments in Denmark

Data and biological material

Patient demografics (gender, age, tumorstage, histololgy) Follow up data (response, toxicity and quality of life) Radiotherapy dose plans

Collaborating researchers and departments

Depatment of Oncology, Aalborg University Hospital

• Rasmus Kjeldsen

Department of Oncology, Aarhus University Hospital

• Azza Khalil

Department of Oncology, Lillebælt Hospital

• Charlotte Kristiansen

Department of Oncology, Odense University Hospital

• Tine Schytte

Department of Oncology, Herlev Hospital

• Gitte Persson

Department of Oncology, Rigshospitalet

• Mette Pohl

Publications associated with the project

Hoffmann L, Persson GF, Nygård L, Nielsen TB, Borrisova S, Gaard-Petersen F, Josipovic M, Khalil AA, Kjeldsen R, Knap MM, Kristiansen C, Møller DS, Ottosson W, Sand H, Thing R, Pøhl 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