NCT02400424

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

4 years

First QC Date

March 11, 2015

Last Update Submit

February 5, 2021

Conditions

Non-small-cell Lung Carcinoma

Keywords

Stereotactic lung radiation therapyRadiochemotherapyUnresectable stage III Non-Small Cell lung CarcinomaPeripheral primary tumor

Outcome Measures

Primary Outcomes (1)

  • Local control rate

    According to RECIST v1.1

    6 months after the end of SBRT

Secondary Outcomes (3)

  • 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

Study Arms (1)

SBRT

EXPERIMENTAL

Study treatment = SBRT for peripheral primary tumor.

Radiation: SBRT

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).

Also known as: Stereotactic body radiation therapy
SBRT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • SCLC or large cell neuroendocrine carcinoma
  • Metastatic disease
  • Stage IVa
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Leon Berard

Lyon, 69373 cedex 08, France

Location

Hopital Nord-Ouest

Villefranche, 69655, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Isabelle IM Martel Lafay, MD

    Center Leon Berard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 27, 2015

Study Start

February 1, 2015

Primary Completion

February 13, 2019

Study Completion

June 25, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

FR(2)