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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01394-43 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arms | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyberknife irradiation | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate overall survival at 24 months and at 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. | 60 months |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study coordinator | Contact | +33 04 92 03 16 61 | DRCI-Promotion@nice.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Recruiting | Nice | 06000 | France |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Evaluate specific survival at 24 months and at 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. | 60 months |
| Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 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. | 24 months |
| Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 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. | 24 months |
| Evaluate overall quality of life before Cyberknife, 1 month post-Cyberknife and 6 months post-Cyberknife | Quality of life will be assessed using the EORTC QLQ-C30 questionnaire (items 29-30) | 6 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |