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

Phase 2RecruitingNCT06627738

Centre Antoine Lacassagne42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cyberknife irradiationRADIATION

Additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in inoperable patients with locally advanced non-small cell lung carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 consent form 9. If applicable, negative pregnancy test\* 10. Eligible for National Health Insurance in France 11. Chest CT scan performed prior to Taxcis 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.

Locations (1)

Centre Antoine Lacassagne

Nice, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 60 months

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.

Time frame: 60 months

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.

Time frame: 24 months

Central Contacts

Study coordinator

CONTACT

+33 04 92 03 16 61 DRCI-Promotion@nice.unicancer.fr

Data from ClinicalTrials.gov

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