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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Antoine Lacassagne
  Nice, France Recruiting

Study contacts

• Study coordinator: Study coordinator
• Email: DRCI-Promotion@nice.unicancer.fr
• Phone: +33 04 92 03 16 61

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.