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Study of the Decrease of Length of Stereotactic Body Radiation Therapy in Lung Cancer (PNEUMOFRAC)

Primary Purpose

Stage IA - IB Non Small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
stereotactic radiotherapy
Sponsored by
Centre Paul Strauss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IA - IB Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologic or cytologic diagnosis of non small cell lung cancer stage IA-IB (T1N0M0 or T2aN0M0)
  • None histologic or cytologic diagnosis of non small cell lung cancer stage IA-IB (T1N0M0 or T2aN0M0) with evolutionary criteria (increase on two successive CT scan and pathological hyperfixation in the TEP scan)
  • Resectable tumor but patient unfit for surgical resection
  • Resectable tumor but patient refusing surgical resection
  • KPS > 60%
  • Pulmonary functions: FEV > 40% theoric value, PO2 ≥ 70mmHg, PCO2 < 50mmHg
  • Patient who can hold appropriate immobilization in dorsal decubitus during approximately 30 minutes
  • Age 18 years or older
  • Not affected by a mental disease
  • Understanding and be informed of the investigational nature of this study and must give written consent prior to the receiving of treatment per this protocol
  • Inscription at the French Social Security

Exclusion Criteria:

  • Patient pregnant
  • Patient deprived of freedom or under guardianship
  • Pulmonary functions : FEV < 40% theoric value, PO2 ≤ 70mmHg, PCO2 > 50mmHg
  • Prior thoracic radiation treatment
  • Prior radiation pneumonitis

Sites / Locations

  • Centre Paul StraussRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stereotactic

Arm Description

Outcomes

Primary Outcome Measures

Minimal tolerated length of treatment of Stereotactic Body Radiation Therapy in the treatment of stage IA - IB non small cell lung cancer (T1N0M0 or T2aN0M0)
The minimal tolerated length of treatment level is determined according to a 3x3 modified Fibonacci method and 4 schedule levels will be explored. The dose of radiation is 60 Gy in 8 fractions of 7,5 Gy. The first treatment schedule level consists of delivering 3 fractions the first week, 2 fractions the second week and 3 fractions the third week. The second treatment schedule level consists of delivering 3 fractions the first week, 3 fractions the second week and 2 fractions the third week. The third treatment schedule level consists of delivering 4 fractions the first week, 2 fractions the second week and 2 fractions the third week. Finally, the fourth treatment schedule level consists of delivering 4 fractions the first week and 4 fractions the second week (duration of the treatment : 2weeks).

Secondary Outcome Measures

Safety and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

First Posted
August 6, 2018
Last Updated
August 11, 2020
Sponsor
Centre Paul Strauss
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1. Study Identification

Unique Protocol Identification Number
NCT03921957
Brief Title
Study of the Decrease of Length of Stereotactic Body Radiation Therapy in Lung Cancer
Acronym
PNEUMOFRAC
Official Title
Phase I/II Study of the Decrease of Length of Stereotactic Body Radiation Therapy in the Treatment of Stage IA - IB Non Small Cell Lung Cancer (T1N0M0 or T2aN0M0)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 24, 2015 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Paul Strauss

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose : Non small cell lung cancer (NSCLC) is among the most common cancers in the werstern world. Patients with stage I have the most satisfactory outcomes. The gold standard for treatment is still surgery, but this approach has recently been challenged by hypofractionnated stereotactic body radiation therapy (SBRT). Therefore, for patients who are not eligible for surgery due to their significant co-morbidity, or for those who refuse surgical resection, stereotactic radiotherapy is an efficient practical alternative. SBRT is well tolerated and efficient, in fact local control rate at 3 years reaches more than 90%. Most of guidelines recommand a dose between 48 and 60 Gy delivered in 3 at 8 fractions and 3 weeks. Biological effect depends on the dose distribution in time and decreases when the number of fractions or length of radiation treatment increase. Decreasing the length of treatment and the interval between fractions may improve efficiency of treatment and local control rate. Moreover, it may improve quality of life of patients. Nevertheless, an evaluation of safety of such shorter treatment course, with a phase I-II clinical study is needed.
Detailed Description
Intervention : Stereotactic Body Radiation Therapy in the treatment of stage IA - IB non small cell lung cancer (T1N0M0 or T2aN0M0) Study type : Interventional Study design : Endpoint classification : safety/efficacy study Intervention model : single group assignment Masking : open label Primary purpose : treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IA - IB Non Small Cell Lung Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
stereotactic
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiotherapy
Intervention Description
first level : W1 : 3 fractions - W2 : 2 fractions - W3 : 3 fractions second level : W1 3 fractions - W2 : 3 fractions - W3 : 3 fractions Third level : W1 : 4 fractions - W2 : 2 fractions - W3 : 2 fractions Fourth level : W1 : 4 fractions - W2 : 4 fractions
Primary Outcome Measure Information:
Title
Minimal tolerated length of treatment of Stereotactic Body Radiation Therapy in the treatment of stage IA - IB non small cell lung cancer (T1N0M0 or T2aN0M0)
Description
The minimal tolerated length of treatment level is determined according to a 3x3 modified Fibonacci method and 4 schedule levels will be explored. The dose of radiation is 60 Gy in 8 fractions of 7,5 Gy. The first treatment schedule level consists of delivering 3 fractions the first week, 2 fractions the second week and 3 fractions the third week. The second treatment schedule level consists of delivering 3 fractions the first week, 3 fractions the second week and 2 fractions the third week. The third treatment schedule level consists of delivering 4 fractions the first week, 2 fractions the second week and 2 fractions the third week. Finally, the fourth treatment schedule level consists of delivering 4 fractions the first week and 4 fractions the second week (duration of the treatment : 2weeks).
Time Frame
22 months
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic diagnosis of non small cell lung cancer stage IA-IB (T1N0M0 or T2aN0M0) None histologic or cytologic diagnosis of non small cell lung cancer stage IA-IB (T1N0M0 or T2aN0M0) with evolutionary criteria (increase on two successive CT scan and pathological hyperfixation in the TEP scan) Resectable tumor but patient unfit for surgical resection Resectable tumor but patient refusing surgical resection KPS > 60% Pulmonary functions: FEV > 40% theoric value, PO2 ≥ 70mmHg, PCO2 < 50mmHg Patient who can hold appropriate immobilization in dorsal decubitus during approximately 30 minutes Age 18 years or older Not affected by a mental disease Understanding and be informed of the investigational nature of this study and must give written consent prior to the receiving of treatment per this protocol Inscription at the French Social Security Exclusion Criteria: Patient pregnant Patient deprived of freedom or under guardianship Pulmonary functions : FEV < 40% theoric value, PO2 ≤ 70mmHg, PCO2 > 50mmHg Prior thoracic radiation treatment Prior radiation pneumonitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie SARTORI
Phone
+33388258541
Email
vsartori@strasbourg.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine ANTONI, Md
Phone
+33388252478
Email
dantoni@strasbourg.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine ANTONI, MD
Organizational Affiliation
Centre Paul Strauss
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine ANTONI, Md
Phone
+33 388 25 24 78
Email
dantoni@strasbourg.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Valérie SARTORI, Md
Phone
+33 388 25 85 41
Email
vsartori@strasbourg.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Delphine ANTONI, Md

12. IPD Sharing Statement

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Study of the Decrease of Length of Stereotactic Body Radiation Therapy in Lung Cancer

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