Non-small-cell Lung Carcinoma
Conditions
Keywords
Stereotactic lung radiation therapy, Radiochemotherapy, Unresectable stage III Non-Small Cell lung Carcinoma, Peripheral primary tumor
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.
Interventions
RADIATIONSBRT
54 Gy in 3 fractions D1-D3-D5. SBRT should be started within 3 to 4 weeks after the end of radiochemotheray (RT-CT).
Sponsors
Centre Leon Berard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control rate | 6 months after the end of SBRT | According to RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to 2 years after the end of SBRT | Incidence of adverse events, assessed using the NCI-CTCAE v4 grading scale |
Countries
France
Outcome results
None listed