Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor

Centre Leon Berard25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small-cell Lung Carcinoma

Interventions

SBRTRADIATION

54 Gy in 3 fractions D1-D3-D5. SBRT should be started within 3 to 4 weeks after the end of radiochemotheray (RT-CT).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Centre Leon Berard

Lyon, France

Hopital Nord-Ouest

Villefranche, France

Outcomes

Primary Outcomes

Local control rate

According to RECIST v1.1

Time frame: 6 months after the end of SBRT

Secondary Outcomes

Overall survival

Time frame: 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

Time frame: 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

Time frame: Up to 2 years after the end of SBRT

Data from ClinicalTrials.gov

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