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.
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. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Stereotactic body radiation therapy: Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation.
Stereotactic body radiation therapy: Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.
Aalborg University Hospital
Aalborg, Denmark
NOT_YET_RECRUITINGAarhus University Hospital
Aarhus, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGHerlev University Hospital
Herlev, Denmark
RECRUITINGOdense University Hospital
Odense, Denmark
RECRUITINGDepartment of Oncology, Lillebaelt Hospital
Vejle, Denmark
RECRUITINGToxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Time frame: Assessed at 6 months
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Time frame: Assessed at 12 months
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Time frame: Assessed at 2 years
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Time frame: Assessed at 5 years
Local progression free survival (LPFS)
Local progression-free survival (LPFS) is defined from the start of radiotherapy treatment until death or date of local recurrence. Events are death and local recurrence.
Time frame: Up to 10 years
Overall survival (OS)
Overall survival (OS) is defined as the time from start of radiotherapy treatment until death by any cause.
Time frame: Up to 10 years
Disease free survival (DFS)
Disease free survival (DFS) is defined from start of radiotherapy treatment until date of first locoregional or metastatic recurrence or death from any cause. Events are recurrence and death.
Time frame: Up to 10 years
Time-to-treatment failure (TTF)
Time-to-treatment failure (TTF) is defined as time from start of radiotherapy treatment until the date of relapse; the patient has withdrawn patient consent or premature termination of SBRT due to toxicity. Events are death due to primary cancer, death due to protocol treatment and date of local, regional or metastatic recurrence.
Time frame: Up to 10 years
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