Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor

Not Applicable

Terminated

• Conditions: Non-small-cell Lung Carcinoma
• Interventions: Radiation: SBRT

• Registration Number: NCT02400424
• Lead Sponsor: Centre Leon Berard

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Primary Completion: 2019-02-13
• Study Completion: 2020-06-25
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT	SBRT	Study treatment = SBRT for peripheral primary tumor.

Primary Outcome Measures

Name	Time	Method
Local control rate	6 months after the end of SBRT	According to RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Centre Leon Berard; 🇫🇷 Lyon, France

Hopital Nord-Ouest; 🇫🇷 Villefranche, France