Carcinoma, Non-small-cell LungPhase 3NCT00349102
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer
A Phase 3 study testing Free breathing and Breath holding in people with Carcinoma, Non-small-cell Lung, run by Centre Leon Berard at 7 sites in France.
Trial summary
The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy. Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small-cell Lung
- What is being tested?
- Free breathing and Breath holding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 7 sitesFrance
- Study dates
- Jul 2006to Jan 2014
- Phase
- Phase 3
- 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
- Non-metastatic cytologically or histologically proven non-small-cell lung cancer (NSCLC)
- Operated NSCLC patients requiring post-surgical irradiation or non-operated NSCLC patients requiring curative irradiation
- Conformational thoracic radiotherapy with curative intent
- Age >= 18
- Complete functional respiratory evaluation (FRE) performed less than 2 months before inclusion, demonstrating a maximum expiratory flow-volume/second > 1 l (in case surgery, the FRE must have been realized in the post-surgery period)
- Thoracic CT-scan performed less than 2 months before inclusion for non-operated patient
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- PET-scan performed less than 2 months before inclusion for non-operated patient
- Performance status (PS) ECOG <= 1
- Possible training on breath holding technique
- Female patients of childbearing potential: effective method of contraception necessary
- Mandatory affiliation with a social security system
- Written, signed, informed consent
Who cannot join
- Small-cell lung cancer
- Metastatic disease
- Infiltrating pulmonary disease
- Previous thoracic irradiation
- Indication of irradiation with palliative intent
- Previous or concurrent primary malignancies at other sites (except basocellular skin cancer or cervical cancer in situ or complete remission for more than 5 years)
Show all 12Show fewer
- Life expectancy < 6 months
- Patient understanding incompatible with the breath-hold technique (patients with major presbycusis are not eligible)
- Pregnant or lactating woman
- Patient included in another clinical trial
- Follow-up difficult
- Patient deprived of freedom
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69008
Institut Curie
Paris, 75005
Hôpital de la Pitié Salpêtrière
Paris, 75013
Hôpital Européen Georges Pompidou
Paris, 75015
Centre Catalan d'Oncologie
Perpignan, 66000
Centre René Gauducheau
Saint-Herblain, 44805
About this study
Official title: Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy
The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy.
Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation.
Read more
The primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation.
Several departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study.
The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.
Read the detailed description
The secondary objectives are:
- Validation of the Lent-Soma toxicity scale by comparison to the RTOG scale,
- Response rate at different times: week 6-8, 1 year and 2 years after the end of irradiation,
- Progression-free survival rate at 1 year and 2 years after the end of irradiation
- Confirmation of the predictive value of serum cytokine levels (IL-6 and IL-10) during irradiation for the occurrence of early radiation toxicity, and analysis of the correlation between these serum levels at inclusion and the expression polymorphism of candidate genes.
- Conditions
- Carcinoma, Non-small-cell Lung
- Being tested
- Free breathing, Breath holding
- Keywords
- Non-small-cell lung cancer, Breath-hold, Radiation pneumonitis, Serum cytokines, LENT-SOMA scale, Non-metastatic non-small-cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free breathingRadiation
Also called Conformal radiation, Lung cancer
Free breathing during conformal radiation
Breath holdingRadiation
Also called Conformal radiation, Lung cancer
Breath holding during conformal radiation
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Free breathing during conformal radiation Receives: Radiation: Free breathing |
| B | Experimental | Breath holding during conformal radiation Receives: Radiation: Breath holding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation
Measured: 6-8 and 10-12 weeks after the end of irradiation
Secondary outcomes (1)
RTOG and LENT-SOMA scores at 6-8 weeks and 10-12 weeks after the end of irradiation, response rates at 6-8 weeks, 1 year and 2 years after irradiation
Measured: 6-8 and 10-12 weeks after the end of irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-small-cell LungStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Line CLAUDE, MD, Principal investigator, Centre Leon Berard, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349102
- Sponsor's protocol ID
- GATING 2006
- Other IDs
- ET2005-052
- Status last verified
- Jan 2017
- First submitted
- 5 Jul 2006
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arpin D, Perol D, Blay JY, Falchero L, Claude L, Vuillermoz-Blas S, Martel-Lafay I, Ginestet C, Alberti L, Nosov D, Etienne-Mastroianni B, Cottin V, Perol M, Guerin JC, Cordier JF, Carrie C. Early variations of circulating interleukin-6 and interleukin-10 levels during thoracic radiotherapy are predictive for radiation pneumonitis. J Clin Oncol. 2005 Dec 1;23(34):8748-56. doi: 10.1200/JCO.2005.01.7145.
PubMed 16314635Claude L, Perol D, Ginestet C, Falchero L, Arpin D, Vincent M, Martel I, Hominal S, Cordier JF, Carrie C. A prospective study on radiation pneumonitis following conformal radiation therapy in non-small-cell lung cancer: clinical and dosimetric factors analysis. Radiother Oncol. 2004 May;71(2):175-81. doi: 10.1016/j.radonc.2004.02.005.
PubMed 15110451L. Falchero, D. Perol, D. Arpin, M. Vincent, M. Perol, JF. Cordier, D. Boutry, I. Martel-Lafay, C. Carrie.- Conséquences fonctionnelles de la radiothérapie thoracique conformationnelle (r3d) et facteurs prédictifs de pneumopathie radique aiguë (PRA) chez des patients atteints de cancer bronchique non à petites cellules (CNPC). Rev. Mal. Resp., 2001 ; 18 (suppl) : 1S102
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy
- ClinicalTrials.gov ID
- NCT00349102
- Acronym / sponsor ID
- GATING 2006
- Conditions
- Carcinoma, Non-small-cell Lung
- Keywords
- Non-small-cell lung cancer, Breath-hold, Radiation pneumonitis, Serum cytokines, LENT-SOMA scale, Non-metastatic non-small-cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jul 2006 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Jul 2006 (estimated)
- 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.
The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy.
Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation.
The primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation.
Several departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study.
The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.
Detailed description
The secondary objectives are:
- Validation of the Lent-Soma toxicity scale by comparison to the RTOG scale,
- Response rate at different times: week 6-8, 1 year and 2 years after the end of irradiation,
- Progression-free survival rate at 1 year and 2 years after the end of irradiation
- Confirmation of the predictive value of serum cytokine levels (IL-6 and IL-10) during irradiation for the occurrence of early radiation toxicity, and analysis of the correlation between these serum levels at inclusion and the expression polymorphism of candidate genes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Radiation: Free breathingFree breathing during conformal radiation |
| B | Experimental | Radiation: Breath holdingBreath holding during conformal radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Non-metastatic cytologically or histologically proven non-small-cell lung cancer (NSCLC)
- Operated NSCLC patients requiring post-surgical irradiation or non-operated NSCLC patients requiring curative irradiation
- Conformational thoracic radiotherapy with curative intent
- Age >= 18
- Complete functional respiratory evaluation (FRE) performed less than 2 months before inclusion, demonstrating a maximum expiratory flow-volume/second > 1 l (in case surgery, the FRE must have been realized in the post-surgery period)
Key exclusion criteria (12 listed)
- Small-cell lung cancer
- Metastatic disease
- Infiltrating pulmonary disease
- Previous thoracic irradiation
- Indication of irradiation with palliative intent
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 |
|---|---|---|
| Free breathingAlso: Conformal radiation, Lung cancerFree breathing during conformal radiation | Radiation | A |
| Breath holdingAlso: Conformal radiation, Lung cancerBreath holding during conformal radiation | Radiation | B |
Primary outcome
Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation
Time frame: 6-8 and 10-12 weeks after the end of irradiation
1 secondary outcome
RTOG and LENT-SOMA scores at 6-8 weeks and 10-12 weeks after the end of irradiation, response rates at 6-8 weeks, 1 year and 2 years after irradiation
Time frame: 6-8 and 10-12 weeks after the end of irradiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Background: PubMed 16314635Arpin D, Perol D, Blay JY, Falchero L, Claude L, Vuillermoz-Blas S, Martel-Lafay I, Ginestet C, Alberti L, Nosov D, Etienne-Mastroianni B, Cottin V, Perol M, Guerin JC, Cordier JF, Carrie C. Early variations of circulating interleukin-6 and interleukin-10 levels during thoracic radiotherapy are predictive for radiation pneumonitis. J Clin Oncol. 2005 Dec 1;23(34):8748-56. doi: 10.1200/JCO.2005.01.7145.
- Background: PubMed 15110451Claude L, Perol D, Ginestet C, Falchero L, Arpin D, Vincent M, Martel I, Hominal S, Cordier JF, Carrie C. A prospective study on radiation pneumonitis following conformal radiation therapy in non-small-cell lung cancer: clinical and dosimetric factors analysis. Radiother Oncol. 2004 May;71(2):175-81. doi: 10.1016/j.radonc.2004.02.005.
- Results publicationL. Falchero, D. Perol, D. Arpin, M. Vincent, M. Perol, JF. Cordier, D. Boutry, I. Martel-Lafay, C. Carrie.- Conséquences fonctionnelles de la radiothérapie thoracique conformationnelle (r3d) et facteurs prédictifs de pneumopathie radique aiguë (PRA) chez des patients atteints de cancer bronchique non à petites cellules (CNPC). Rev. Mal. Resp., 2001 ; 18 (suppl) : 1S102
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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.
Line CLAUDE, MD principal investigator
Centre Leon Berard, Lyon
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Free breathing and Breath holding in people with Carcinoma, Non-small-cell Lung, run by Centre Leon Berard at 7 sites 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation (time frame: 6-8 and 10-12 weeks after the end of irradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00349102, which also lists 3 linked publications.
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 1 Feb 2017.