Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor (GFPC_01-14)

Léon Bérard Center

Status: Terminated

Conditions: Non-small-cell Lung Carcinoma

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02400424

GFPC 01-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

SBRT

Experimental group

Description:

Study treatment = SBRT for peripheral primary tumor.

Treatment:

Radiation: SBRT