Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma (NSCLC) with peripheral primary tumor. Evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage III NSCLC having a peripheral primary tumor. The number of patients required in this multicenter prospective study is 70. This is a prospective, multicenter, non comparative and non randomized study.

Detailed Description
-----------------
Stereotactic radiotherapy or SBRT (Body Stereotactic Radiation Therapy) allows to irradiate with high dose limited lesions size with a local control surrounding of 80-98% and with a low level of toxicity. We propose to realize a classic concomitant RT-CT for mediastinal irradiation and combine this treatment with stereotactic RT for peripheral primary tumor. The estimated inclusion period is approximately 3 years. Follow-up duration for each patient is 2 years. The duration of the research is 5 years.

Official Title
-----------------
Multicenter Prospective Study of the Efficacy of Stereotactic Lung Radiation Therapy After Concomitant Radio-chemotherapy for Unresectable Stage III Non-small Cell Lung Carcinoma (NSCLC) With Peripheral Primary Tumor.

Conditions
-----------------
Non-small-cell Lung Carcinoma

Intervention / Treatment
-----------------
* Radiation: SBRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years ≤ Age ≤ 75 years PS ECOG 0 or 1 Histologically proven NSCLC Unresectable stage III: T1 or T2 or T3 ≤ 5 cm AND N2 or N3 (only contralateral mediastinum or homolateral supraclavicular). Peripheral primary tumor ≥ 1 cm and ≤ 5 cm Possible concomitant chemoradiotherapy : 1 cure induction and 3 concomitant cycles of chemotherapy with cisplatin and Navelbine ® and 3D conformal radiotherapy delivering 66 Gy in 33 fractions to the mediastinal lymph node involvement without treating the peripheral tumor. Adequate biological parameters Forced expiratory volume (FEV) ≥1 liter or ≥ 30% of the theoretical value Patient covered by a health insurance scheme Signed informed consent Exclusion Criteria: SCLC or large cell neuroendocrine carcinoma Metastatic disease Stage IVa Pregnant or breast-feeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT<br>Study treatment = SBRT for peripheral primary tumor. | Radiation: SBRT<br>* 54 Gy in 3 fractions D1-D3-D5. SBRT should be started within 3 to 4 weeks after the end of radiochemotheray (RT-CT).<br>* Other names: Stereotactic body radiation therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate | According to RECIST v1.1 | 6 months after the end of SBRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | From date of inclusion until the date of death from any cause, assessed up to 24 months after the end of SBRT | 
| Progression-free survival |  | From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after the end of SBRT | 
| Safety (adverse events, assessed using the NCI-CTCAE v4 grading scale) | Incidence of adverse events, assessed using the NCI-CTCAE v4 grading scale | Up to 2 years after the end of SBRT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stereotactic lung radiation therapy, Radiochemotherapy, Unresectable stage III Non-Small Cell lung Carcinoma, Peripheral primary tumor