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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 scan after neoadjuvant treatment meeting the following criteria:

‣ 1 to 3 target volumes of less than 5 cm in greatest diameter

⁃ And enabling additional irradiation 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

Locations
Other Locations
France
Centre Antoine Lacassagne
RECRUITING
Nice
Contact Information
Primary
Study coordinator
DRCI-Promotion@nice.unicancer.fr
+33 04 92 03 16 61
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2033-06
Participants
Target number of participants: 37
Treatments
Experimental: Experimental Arms
After their radiochemotherpy (Taxcis protocol), the eligible patients will be included in the study and will have a Cyberknife boost (5 sessions of 8 Gray, over 2 weeks maximum). They will have follow-up visits for 2 years post-treatment. Then, their disease and survival status will be recorded until 5 years post-treatment.
Sponsors
Leads: Centre Antoine Lacassagne

This content was sourced from clinicaltrials.gov

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