Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost
Recruiting
Phase 2Interventional Study
Carcinoma, Non-Small-Cell Lung
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
Centre Antoine Lacassagne · Other
Who this trial is looking for
This trial is looking for adults with a specific type of lung cancer who cannot have surgery right now. Participants will receive chemotherapy and radiation treatment, with the chance of an additional CyberKnife radiation boost.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I have been diagnosed with non-small cell lung cancer
I have stage III lung cancer that cannot be operated on
I have received specific chemotherapy and radiation treatments
I have a CT scan of my chest showing my tumor size
I can safely have a venous device implanted
I can read information about the trial and give my consent
I have a negative pregnancy test if applicable
You may not be able to join if
I have a positive EGFR mutation
I have severe heart failure or related breathing problems
I have had heart problems in the last three months
My lung function tests show I cannot receive radiation
I have side effects from previous treatments that prevent further radiation
I am pregnant or breastfeeding and do not meet specific criteria
I cannot give consent or am under legal protection
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 \&…
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.
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