Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor

Non-small-cell Lung Carcinoma Clinical Trial

— GFPC_01-14  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02400424
• Other study ID #: GFPC 01-14
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 25, 2020

Study information

• Verified date: February 2021
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 25, 2020
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Carcinoma

Intervention

Radiation:
• 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).

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon
France	Hopital Nord-Ouest	Villefranche

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate	According to RECIST v1.1	6 months after the end of SBRT
Secondary	Overall survival		From date of inclusion until the date of death from any cause, assessed up to 24 months after the end of SBRT
Secondary	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
Secondary	Safety (adverse events, assessed using the NCI-CTCAE v4 grading scale)	Incidence of adverse events, assessed using the NCI-CTCAE v4 grading scale	Up to 2 years after the end of SBRT