LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC

Lung cancer is the leading cause of cancer death worldwide with a crude incidence of lung cancer in the European Union of 52/100.000 per year and a mortality of 47/100.000 per year. Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all cases. The five year survival of NSCLC patients is quite poor (16%), mainly due to patients being diagnosed at advanced stages. However if lung cancer can be detected and treated at an earlier stage the outcome and survival is much more favorable with five year survival rates up to 77%. The current standard of care for small volume tumors is surgical resection in medically fit patients, consisting in lobectomy or pneumonectomy accompanied by a systematic mediastinal lymph node sampling or lymphadenectomy. For the patient population with small volume disease at early stage surgery offers the potential of local tumor control in up to 96% of the patients. However, about one quarter of the patients is medically inoperable because of coexisting morbidities or poor general condition, mostly the result of a long smoking history and consecutive chronic Obstructive pulmonary disease (COPD) and coronary artery disease (CAD). The main purpose of this trial is to assess the effectiveness of IG-SBRT (Image guided stereotactic body radiotherapy) in patients with medically inoperable early stage, centrally located NSCLC and in those who are not willing to undergo surgical treatment. Secondary objectives of the study are * to assess safety of the treatment modality by collecting data about acute and late toxicity * patterns of local and distant recurrence and relation between the site of local recurrence and the clinical (CTV) and planning target volume (PTV) * survival and cause of death

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Diagnosis of non-small cell lung cancer (NSCLC), either confirmed by histology or cytology
* Patient deemed medically inoperable after assessment in a multimodality tumor board or refusing surgery
* Tumor size \< 5 cm, or 5-7 cm (strict separate stopping rules will be applied for the latter population)
* Central tumor location i.e. tumor in or abutting a zone within 2 cm of the proximal bronchial tree or other parts of the mediastinum, eligibility of each case underlying expert review
* Staging- whole body FDG-PET/CT acquired within 4 weeks prior to inclusion. In case of uncertainty about affection of hilar/mediastinal nodes, endobronchial ultrasound-transbronchial needle aspiration(EBUS-TBNA) is strongly recommended
* N0 tumors
* T3 tumors only if: not within the mediastinum and not abutting the oesophagus and only one lesion
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Age ≥ 18 years
* Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* Before patient registration, written informed consent must be given according to International Conference on Harmonization /Good Clinical Practice (ICH/GCP), and national/local regulations

Exclusion Criteria:

* No prior RT of chest and/or mediastinum
* No chemotherapy and/or targeted treatment within 3 months before the onset of RT

• DERIVEDLevy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available. PMID 26104945