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

Primary Purpose

Non-small-cell Lung Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SBRT
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small-cell Lung Carcinoma focused on measuring Stereotactic lung radiation therapy, Radiochemotherapy, Unresectable stage III Non-Small Cell lung Carcinoma, Peripheral primary tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Leon Berard
  • Hopital Nord-Ouest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT

Arm Description

Study treatment = SBRT for peripheral primary tumor.

Outcomes

Primary Outcome Measures

Local control rate
According to RECIST v1.1

Secondary Outcome Measures

Overall survival
Progression-free survival
Safety (adverse events, assessed using the NCI-CTCAE v4 grading scale)
Incidence of adverse events, assessed using the NCI-CTCAE v4 grading scale

Full Information

First Posted
March 11, 2015
Last Updated
February 5, 2021
Sponsor
Centre Leon Berard
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1. Study Identification

Unique Protocol Identification Number
NCT02400424
Brief Title
Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
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
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
June 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Carcinoma
Keywords
Stereotactic lung radiation therapy, Radiochemotherapy, Unresectable stage III Non-Small Cell lung Carcinoma, Peripheral primary tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBRT
Arm Type
Experimental
Arm Description
Study treatment = SBRT for peripheral primary tumor.
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
Stereotactic body radiation therapy
Intervention Description
54 Gy in 3 fractions D1-D3-D5. SBRT should be started within 3 to 4 weeks after the end of radiochemotheray (RT-CT).
Primary Outcome Measure Information:
Title
Local control rate
Description
According to RECIST v1.1
Time Frame
6 months after the end of SBRT
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
From date of inclusion until the date of death from any cause, assessed up to 24 months after the end of SBRT
Title
Progression-free survival
Time Frame
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
Title
Safety (adverse events, assessed using the NCI-CTCAE v4 grading scale)
Description
Incidence of adverse events, assessed using the NCI-CTCAE v4 grading scale
Time Frame
Up to 2 years after the end of SBRT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle IM Martel Lafay, MD
Organizational Affiliation
Center Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373 cedex 08
Country
France
Facility Name
Hopital Nord-Ouest
City
Villefranche
ZIP/Postal Code
69655
Country
France

12. IPD Sharing Statement

Learn more about this trial

Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor

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