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Trial Title:
Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost
NCT ID:
NCT06627738
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Cyberknife irradiation
Description:
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
Arm group label:
Experimental Arms
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.
Criteria for 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 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
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
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Zip:
06000
Country:
France
Contact:
Last name:
Study coordinator
Email:
DRCI-Promotion@nice.unicancer.fr
Investigator:
Last name:
Pierre-Yves BONDIAU
Email:
Principal Investigator
Start date:
January 2025
Completion date:
March 2033
Lead sponsor:
Agency:
Centre Antoine Lacassagne
Agency class:
Other
Source:
Centre Antoine Lacassagne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06627738
