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

August 11, 2020 updated by: Centre Paul Strauss

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
22 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Paul Strauss

Investigators

  • Principal Investigator: Delphine ANTONI, MD, Centre Paul Strauss

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2015

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-001
  • 2017-004658-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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