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

Centre Antoine Lacassagne

Status and phase: Enrolling; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Radiation: Cyberknife irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT06627738

2022/17

2024-A01394-43 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Experimental Arms

Experimental group

Description:

After their radiochemotherpy (Taxcis protocol), the eligible patients will be included in the study and will have a Cyberknife boost (5 sessions of 8 Gray, over 2 weeks maximum). They will have follow-up visits for 2 years post-treatment. Then, their disease and survival status will be recorded until 5 years post-treatment.

Treatment:

Radiation: Cyberknife irradiation