Adding a CyberKnife boost after chemoradiation for locally advanced non-small-cell lung cancer

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

This trial will try giving a targeted CyberKnife radiation boost after standard platinum-based induction and concurrent chemoradiation to see if it improves outcomes for adults with unresectable stage III non-small-cell lung cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Antoine Lacassagne (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nice)
• Trial ID: NCT06627738 on ClinicalTrials.gov

What this trial studies

This is a monocentric, non-randomized, open-label phase II trial testing whether an additional stereotactic CyberKnife boost improves results after standard platinum-doublet induction chemotherapy followed by concurrent chemoradiation in patients with locally advanced, unresectable NSCLC. Eligible patients have completed at least two cycles of induction chemotherapy and at least 40 Gy of concurrent radiotherapy with 1–3 residual target volumes under 5 cm that can safely receive a CyberKnife boost according to organ-at-risk constraints. The trial is designed as a superiority study with an interim analysis to monitor outcomes. Primary interest is on local control and treatment tolerability following the boost.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed stage III non-metastatic NSCLC, ECOG 0–2, who have completed two cycles of platinum-based induction chemotherapy and at least 40 Gy with concomitant platinum-based chemotherapy and who have 1–3 residual lesions under 5 cm amenable to CyberKnife planning are ideal candidates.

Not a fit: Patients with metastatic disease, tumors too large or located such that organ-at-risk dose constraints cannot be met, severe comorbidities or poor performance status, or inability to attend the single-center site are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, adding a focused CyberKnife boost could improve local tumor control and possibly survival while limiting damage to surrounding healthy tissue.

How similar studies have performed: Previous small series and single-center reports of stereotactic boosts after chemoradiation have suggested improved local control in select patients, but randomized evidence is limited and the approach remains relatively experimental.

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 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.

Where this trial is running

Nice

• Centre Antoine Lacassagne — Nice, France (RECRUITING)

Study contacts

• Study coordinator: Study coordinator

Conditions: Carcinoma, Non-Small-Cell Lung