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

NCT ID: NCT03921957

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-24
• Study Completion Date: 2021-12-31

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

Conditions

Stage IA - IB Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stereotactic

Group Type: EXPERIMENTAL

stereotactic radiotherapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Paul Strauss

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Delphine ANTONI, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Paul Strauss

Locations

Centre Paul Strauss

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Valérie SARTORI

Role: CONTACT

vsartori@strasbourg.unicancer.fr

+33388258541

Delphine ANTONI, Md

Role: CONTACT

dantoni@strasbourg.unicancer.fr

+33388252478

Facility Contacts

Delphine ANTONI, Md

Role: primary

dantoni@strasbourg.unicancer.fr

+33 388 25 24 78

Valérie SARTORI, Md

Role: backup

vsartori@strasbourg.unicancer.fr

+33 388 25 85 41

Other Identifiers

2017-004658-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2015-001

Identifier Type: -

Identifier Source: org_study_id