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NCT Number: NCT06627738

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Antoine Lacassagne

Nice, 06000, France

Location status: Recruiting

Location contact

Pierre-Yves BONDIAU

PRINCIPAL_INVESTIGATOR

Study coordinator

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years old or more
  • ECOG 0 to 2
  • Histologically proven non-small cell lung cancer
  • Stage III non-metastatic tumor, not allowing for immediate surgery
  • 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
  • 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)
  • No contraindication to implantable venous devices (IVDs)
  • Patient who has read the patient information note and signed the consent form
  • If applicable, negative pregnancy test*
  • Eligible for National Health Insurance in France
  • Chest CT scan performed prior to Taxcis

Exclusion criteria

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

Treatment and study plan

Cyberknife irradiation

Radiation

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

Primary outcomes

  1. 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).

    Time frame: 24 months

    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.

Secondary outcomes

  1. Evaluate overall survival at 24 months and at 60 months

    Time frame: 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.

  2. Evaluate specific survival at 24 months and at 60 months

    Time frame: 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.

  3. Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months

    Time frame: 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.

  4. Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months

    Time frame: 24 months

    The overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy throughout patient participation will be evaluated by clinical and biological means and rated according to the NCI CTCAE V5.0 scale.

  5. Evaluate overall quality of life before Cyberknife, 1 month post-Cyberknife and 6 months post-Cyberknife

    Time frame: 6 months

    Quality of life will be assessed using the EORTC QLQ-C30 questionnaire (items 29-30)

Study contacts

Contact information is provided by the study sponsor or research team.

Study coordinator

CONTACT

[email protected]

+33 04 92 03 16 61

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Acronym: Cybertaxcis II

Important dates

Study start
2025
Primary completion
2034
Study completion
2034
First posted
Oct 4, 2024
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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