Stage IA - IB Non Small Cell Lung CancerPNEUMOFRACNCT03921957
Study of the Decrease of Length of Stereotactic Body Radiation Therapy in Lung Cancer
A study testing stereotactic radiotherapy in people with Stage IA - IB Non Small Cell Lung Cancer, run by Centre Paul Strauss at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IA - IB Non Small Cell Lung Cancer
- What is being tested?
- stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2015to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Paul Strauss
Strasbourg, 67065
Delphine ANTONI, Md, +33 388 25 24 78, dantoni@strasbourg.unicancer.fr
Valérie SARTORI, Md, +33 388 25 85 41, vsartori@strasbourg.unicancer.fr
About this study
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)
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.
Read the 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
- Being tested
- stereotactic radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiotherapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| stereotactic | Experimental | Not described Receives: Radiation: stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 22 months
Secondary outcomes (1)
Safety and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start24 Nov 2015
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IA - IB Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine ANTONI, MD, Principal investigator, Centre Paul Strauss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921957
- Sponsor's protocol ID
- 2015-001
- Other IDs
- 2017-004658-41, 2017
- Acronym
- PNEUMOFRAC
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2018
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03921957
- Acronym / sponsor ID
- PNEUMOFRAC / 2015-001
- Conditions
- Stage IA - IB Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stereotactic | Experimental | Radiation: stereotactic radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic radiotherapyfirst 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 | Radiation | stereotactic |
Primary outcome
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).
1 secondary outcome
Safety and tolerability
Time frame: 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine ANTONI, MD principal investigator
Centre Paul Strauss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic radiotherapy in people with Stage IA - IB Non Small Cell Lung Cancer, run by Centre Paul Strauss at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valérie SARTORI (+33388258541, vsartori@strasbourg.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.