Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-06-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-small-cell Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT

Study treatment = SBRT for peripheral primary tumor.

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

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

Interventions

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SBRT

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

Intervention Type RADIATION

Other Intervention Names

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Stereotactic body radiation therapy

Eligibility Criteria

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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