NCT06627738 Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost
| NCT ID | NCT06627738 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Antoine Lacassagne |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2034-02 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 years old or more 2. ECOG 0 to 2 3. Histologically proven non-small cell lung cancer 4. Stage III non-metastatic tumor, not allowing for immediate surgery 5. 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 6. 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) 7. No contraindication to implantable venous devices (IVDs) 8. Patient who has read the patient information note and signed the c