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

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ClinicalTrials.gov Identifier: NCT03921957
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Paul Strauss

Study Description
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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.


Condition or disease Intervention/treatment Phase
Stage IA - IB Non Small Cell Lung Cancer Radiation: stereotactic radiotherapy Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 24, 2015
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: stereotactic Radiation: stereotactic radiotherapy
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


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: 22 months ]

    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 :
  1. Safety and tolerability [ Time Frame: 22 months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921957


Contacts
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Contact: Valérie SARTORI +33388258541 vsartori@strasbourg.unicancer.fr
Contact: Delphine ANTONI, Md +33388252478 dantoni@strasbourg.unicancer.fr

Locations
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France
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Delphine ANTONI, Md    +33 388 25 24 78    dantoni@strasbourg.unicancer.fr   
Contact: Valérie SARTORI, Md    +33 388 25 85 41    vsartori@strasbourg.unicancer.fr   
Principal Investigator: Delphine ANTONI, Md         
Sponsors and Collaborators
Centre Paul Strauss
Investigators
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Principal Investigator: Delphine ANTONI, MD Centre Paul Strauss
More Information
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Responsible Party: Centre Paul Strauss
ClinicalTrials.gov Identifier: NCT03921957    
Other Study ID Numbers: 2015-001
2017-004658-41 ( EudraCT Number )
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms