Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost
Recruiting · NCT06627738 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Antoine Lacassagne
View the official record on ClinicalTrials.gov →Interventions studied
Cyberknife irradiation
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
- 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.
Where it is running
1 location listed.
- Centre Antoine Lacassagne - Nice, France