This is a monocentric, non-randomized, open-label, superiority phase II clinical investigation evaluating the efficacy of additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC), with an interim analysis.
Patients aged 18 years old or more
ECOG 0 to 2
Histologically proven non-small cell lung cancer
Stage III non-metastatic tumor, not allowing for immediate surgery
Positive EGFR mutation
Exercise-induced dyspnea associated with heart failure equal to or greater than stage III of the New York Heart Association (NYHA) classification, (appendix 3)
Coronary syndrome or heart failure in the last three months
Pulmonary function test contraindicating radiotherapy: PFT-FEV1 inferior to 1 L.
Single group
Cyberknife irradiation
RadiationAdditional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in inoperable patients with locally advanced non-small cell lung carcinoma
To evaluate progression-free survival at 24 months after additional Cyberknife irradiation following concomitant radio-chemotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC).
Progression-free survival at 24 months will be assessed by calculating the time between the date of inclusion and the date of progression (according to RECIST 1.1 criteria) or death from any cause whichever come first. Patients who have not progressed, died or been lost to follow-up at the time of analysis will be censored at the date of last news.
Evaluate overall survival at 24 months and at 60 months
Overall survival at 24 months and at 60 months will be assessed by calculating the time between the date of inclusion and the date of death from all causes. Patients who have not died or been lost to follow-up at the time of analysis will be censored at the date of last news.
Evaluate specific survival at 24 months and at 60 months
Specific survival at 24 months and at 60 months will be assessed by calculating the time between the inclusion and the date of cancer-related death. Patients who have not died or been lost to follow-up at the time of analysis will be censored at the date of last news.
Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months
The overall response rate (complete or partial response, stabilization, progression) at 24 months will be defined by RECIST v 1.1 criteria. The objective response rate (CR or PR) will be estimated as the number of patients with a documented complete or partial response, divided by the number of analyzable patients, described for each evaluation. The median duration of response will be given with its 95% confidence interval.
Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months
The overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy throughout patient participation will be evaluated by clinical and biological means and rated according to the NCI CTCAE V5.0 scale.
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