Study of the Efficacy of SBRT on Unresectable Peripheral... | NCT02400424

Studies
Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor

NCT02400424

Sponsor

Centre Leon Berard

Status

Terminated

Last Update Posted

Feb 9, 2021Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Non-small-cell Lung Carcinoma

Interventions

SBRT

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Approval of adjuvant durvalumab after RT-CT (not anticipated in the study design) and small number of stage III NSLCL patients with peripheral tumor accessible to SBRT

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Feb 13, 2019Actual

Completion Date

Jun 25, 2020Actual

First Submitted Date

Mar 11, 2015

First Submission Date that Met QC Criteria

Mar 26, 2015

First Posted Date

Mar 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2021

Last Update Posted Date

Feb 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SBRT	Experimental	Study treatment = SBRT for peripheral primary tumor.	Radiation: SBRT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SBRT	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).	SBRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local control rate	According to RECIST v1.1	6 months after the end of SBRT

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle IM Martel Lafay, MD	Center Leon Berard	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Leon Berard		Lyon		69373 cedex 08	France
Hopital Nord-Ouest

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016634	Radiosurgery

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided