Clinical trial NCT03921957: Study of the Decrease of Length of Stereotactic Body Radiation Therapy in Lung Cancer
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
Overall status: UNKNOWN
Phase: NA
Conditions: Stage IA - IB Non Small Cell Lung Cancer
Lead sponsor: Centre Paul Strauss
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 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)
timeFrame: 22 months
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 22 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre Paul Strauss
Study officials:
affiliation: Centre Paul Strauss
name: Delphine ANTONI, MD
role: PRINCIPAL_INVESTIGATOR
References: