Clinical trial NCT06627738: Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost
Official title: Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 scan after neoadjuvant treatment meeting the following criteria:

   * 1 to 3 target volumes of less than 5 cm in greatest diameter
   * And enabling additional irradiation 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 consent form
9. If applicable, negative pregnancy test\*
10. Eligible for National Health Insurance in France

Exclusion Criteria:

1. Positive EGFR mutation
2. Exercise-induced dyspnea associated with heart failure equal to or greater than stage III of the New York Heart Association (NYHA) classification, (appendix 3)
3. Coronary syndrome or heart failure in the last three months
4. Pulmonary function test contraindicating radiotherapy: PFT-FEV1 inferior to 1 L.
5. After radio-chemotherapy, presence of any toxicity contraindicating Cyberknife irradiation
6. 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.

Primary outcomes:
measure: 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).
timeFrame: 24 months
Secondary outcomes:
measure: Evaluate overall survival at 24 months and at 60 months
timeFrame: 60 months
measure: Evaluate specific survival at 24 months and at 60 months
timeFrame: 60 months
measure: Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months
timeFrame: 24 months
measure: Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months
timeFrame: 24 months
measure: Evaluate overall quality of life before Cyberknife, 1 month post-Cyberknife and 6 months post-Cyberknife
timeFrame: 7 months
measure: Identify 18FDG PET/CT imaging biomarkers, at baseline (such as Total tumor metabolic volume) or on early follow-up scans (such as PERCIST criteria or residual tumor volume), to predict overall survival at 24 months and at 60 months
timeFrame: 60 months
measure: Identify 18FDG PET/CT imaging biomarkers, at baseline (such as Total tumor metabolic volume) or on early follow-up scans (such as PERCIST criteria and residual tumor volume), to predict progression-free survival at 24 months and at 60 months
timeFrame: 60 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
References: