Clinical trial NCT02400424: Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-small-cell Lung Carcinoma
Keywords: Stereotactic lung radiation therapy
Radiochemotherapy
Unresectable stage III Non-Small Cell lung Carcinoma
Peripheral primary tumor
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Local control rate
timeFrame: 6 months after the end of SBRT
Secondary outcomes:
measure: Overall survival
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 24 months after the end of SBRT
measure: Progression-free survival
timeFrame: 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
measure: Safety (adverse events, assessed using the NCI-CTCAE v4 grading scale)
timeFrame: Up to 2 years after the end of SBRT
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Leon Berard
city: Villefranche
country: France
facility: Hopital Nord-Ouest
Study officials:
affiliation: Center Leon Berard
name: Isabelle IM Martel Lafay, MD
role: PRINCIPAL_INVESTIGATOR
References: