Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost

Korábbi kezelés

• Pulmonary function test contraindicating radiotherapy: PFT-FEV1 inferior to 1 L.
• After radio-chemotherapy, presence of any toxicity contraindicating Cyberknife irradiation
• Vulnerable populations and participants as defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017:
  • Incapacitated participants who have not given or refused informed consent prior to the onset of their incapacity, who are not under the provisions of article 64 ;
  • Pregnant or breast-feeding women who are not covered by the provisions of article 66 ;
  • Adults under legal protection or unable to express their consent.

Más betegség

• 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

Laborértékek

• Positive EGFR mutation

• 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
• Volume(s) on the evaluation chest CT scan done at the end of conventional radiotherapy (between 34 \& 46 Gy) meeting the following criteria:
  • 1 to 3 target volumes of less than 5 cm in greatest diameter
  • And allowing for the delivery of a CyberKnife boost to be carried out in compliance with the manufacturer requirements and with the doses delivered to the organs at risk (OAR/fractions) defined in appendix 2
• Patients who have received a " Taxcis " treatment consisting in 2 cycles of induction chemotherapy (platinium-based doublet) and then at least 40 Gy of irradiation in combination with at least 2 cycles of concomitant chemotherapy (platinium-based doublet)
• No contraindication to implantable venous devices (IVDs)
• Patient who has read the patient information note and signed the consent form
• If applicable, negative pregnancy test*
• Eligible for National Health Insurance in France
• Chest CT scan performed prior to Taxcis