Study of the Decrease of Length of Stereotactic Body Radiation Therapy in Lung Cancer
PNEUMOFRAC
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)
2 other identifiers
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2015
CompletedFirst Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 12, 2020
August 1, 2020
6.1 years
August 6, 2018
August 11, 2020
Conditions
Outcome Measures
Primary Outcomes (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)
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 Outcomes (1)
Safety and tolerability
22 months
Study Arms (1)
stereotactic
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Paul Strauss
Strasbourg, 67065, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Delphine ANTONI, MD
Centre Paul Strauss
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2018
First Posted
April 19, 2019
Study Start
November 24, 2015
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
August 12, 2020
Record last verified: 2020-08