The options for patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for a standard definitive chemoradiotherapy regime are meagre. These are patients who are not fit for a chemoradiotherapy schedule of 66 Gy in 2 Gy fractions due to either tumour extent, resulting in excessive dose to the healthy tissue in the thorax, or with performance status not supporting seven weeks of intensive treatment.
The aim is to study the efficiency as well as the safety of a new treatment option of heterogeneously hypofractionated radiotherapy for patients with locally advanced NSCLC who are not candidates for standard, high-dose chemoradiotherapy, either due to excessive irradiation of normal tissue (defined as category A patients) or due to fragility of the patient (category B patients).
Histologically or cytological confirmed locally advanced, inoperable NSCLC.
Age ≥18 years.
Signed informed consent.
Performance status 0-2.
Prior radiotherapy to the thorax, unless there is no significant overlap of current treatment volumes with previous treatment fields.
Dose plan conforming to protocol planning criteria not possible.
Uncontrolled metastatic disease.
Other active malignant disease.
Parallel
Heterogeneously Hypofractionated Radiotherapy
RadiationA heterogeneous hypofractionated schedule for the treatment of high-risk locally advanced NSCLC patients in which the central idea is to decrease dose to normal tissue by ascribing a heterogeneous dose to the PTV. The dose to the periphery of the PTV as well as to the majority of lymph node targets is decreased compared to a standard treatment. The gross volume of the primary tumour and bulky lymph nodes receive mean doses of up to 66 Gy in 24 fractions, and thus receive a hypofractionated higher biological effective dose than standard 66 Gy in 33 fractions.
Overall survival
One year overall survival rate calculated from raditherapy start day
Time to locoregional failure
Cumulative incidence estimate of locoregional failure calculated from radiotherapy start
Incidence of acute toxicity
Incidence of acute toxicity, Dysphagia, cough and pneumonitis evaluated by NCI- CTCAE v 4 grade ≥ 3 and grade 5 will be evaluated, with acute toxicity summarized as worst grade during treatment
Incidence of late toxicity
Incidence of late toxicity grade ≥ 3 and grade 5 will be evaluated using CTC, as cumulative incidence of toxicity events.NCI- CTCAE v 4
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Danish Lung Cancer Group
Lead sponsor
Odense University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Vejle Hospital
Collaborator
Herlev Hospital
Collaborator
Aarhus University Hospital
Collaborator
