Centre Antoine Lacassagne
Nice, 06000, France
Location status: Recruiting
NCT Number: NCT06627738
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Nice, 06000, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
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.
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.
Time frame: 6 months
Quality of life will be assessed using the EORTC QLQ-C30 questionnaire (items 29-30)
Contact information is provided by the study sponsor or research team.
Centre Antoine Lacassagne
Other
Acronym: Cybertaxcis II
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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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