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Recruiting NCT06627738

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

Phase II Interventional Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cyberknife irradiation.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Radiation Cyberknife irradiation
    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 outcome measures

  • 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]
Secondary outcome measures (5)
  • Evaluate overall survival at 24 months and at 60 months [Time frame: 60 months]
  • Evaluate specific survival at 24 months and at 60 months [Time frame: 60 months]
  • Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months [Time frame: 24 months]
  • Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months [Time frame: 24 months]
  • Evaluate overall quality of life before Cyberknife, 1 month post-Cyberknife and 6 months post-Cyberknife [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Centre Antoine Lacassagne — Nice

Identifiers

NCT: NCT06627738 · 2022/17 · 2024-A01394-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗