Non-small Cell Lung CancerPhase 2midPNCT01635270
Phase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma
A Phase 2 study testing mid-position radiation strategy and ITV in people with Non-small Cell Lung Cancer and Radiation Therapy, run by Centre Leon Berard at 1 site in France.
Trial summary
The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Radiation Therapy, Locally Advanced Disease
- What is being tested?
- mid-position radiation strategy and ITV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2012to Aug 2020
- Phase
- Phase 2
- 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
- patient with a NSCLC, non-resected, non-metastatic including a parenchyma portion
- Age >= 18 years
- PS <=2
- CT-scan within 3 months at inclusion
- PET-scan within 3 months at inclusion
- Respiratory functional exploration within 3 months at inclusion
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- estimated V20 (by radiotherapist)< 35% on conventional pre-radiotherapy imaging
- Tumor T0 to T4, M0; N1, N2 ou N3 by isolateral supra-clavicular involvement
- Measurable disease according to RECIST criteria 1.1
- Curative intent Chest conventional radiation therapy
- Radiation indication validated by a multidisciplinary meeting
- Adequate contraceptive method for the whole study duration and for up to 28 days after the end of radiation
- Mandatory affiliation with a health insurance company
- Patients must provide dated \& written consent
Who cannot join
- Prior surgery for NSCLC
- NSCLC nearby pulmonary apex or strictly intra-thoracic with no intra-parenchyma portion
- Metastatic disease or N3 contralateral lymph node
- History of chest irradiation
- History of known increased intrinsic radiosensibility
- Hypersensibility to active substance or excipient of fluoro-deoxyglucose-18F
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- Life expectancy < 6 months
- Patient with a concurrent malignancy or with a history of malignancy (excepted adequately treated basal cell skin carcinoma or cervical squamous cell carcinoma or other malignancies free of the disease for at least 5 years)
- Pregnant or breastfeeding women
- Psychological, sociological or geographical conditions that would limit compliance with study requirements
- Patient deprived of freedom
- Patient has concomitant participation to an other investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase 2 Study Evaluating the Interest of Mid-position Strategy Versus ITV (Internal Target Volume) Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-resected Non-small Cell Lung Carcinoma (NSCLC).
The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.
- Conditions
- Non-small Cell Lung Cancer, Radiation Therapy, Locally Advanced Disease, Non-metastatic Disease, Non-resectable Disease
- Being tested
- mid-position radiation strategy, ITV
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mid-position radiation strategyRadiation
The midP strategy defines the target as the time weighted average tumor position (mid-position) plus an additional margin, computed specifically for each patient, that takes into account the tumor motion in each direction. This strategy can help to safely reduce toxicity while preserving treatment efficacy
ITVRadiation
The ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion.
| Study group | Role | What they receive |
|---|---|---|
| midP arm | Experimental | Patients treated with midP radiotherapy strategy. Receives: Radiation: mid-position radiation strategy |
| ITV arm | Active comparator | Patient treated with radiotherapy ITV strategy Receives: Radiation: ITV |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year Progression Free Survival rate
Efficacy evaluation of the midP strategy in comparison with ITV strategy in patient with locally advanced, non-resected NSCL cancer treated with radiotherapy
Measured: 1 year
Secondary outcomes (3)
Local tumor control rate
Measured: 1 year and 2 years after the end of irradiation
Overall survival
Measured: 1 year and 2 years post irradiation
To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration
Measured: Week1; Week 2; Week3; Week4; Week5; Week6; Week7 during the radiation, then 4 weeks, 3 months; 6 months ,one year and 2 years after the irradiation beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study start12 Sep 2012
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- CREATIS Laboratory
- Responsible party
- Sponsor
- Investigators
- Line CLAUDE, MD, Principal investigator, Centre Léon Bérard, Lyon, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635270
- Sponsor's protocol ID
- midP
- Other IDs
- 2012-A00413-40, ET12-033
- Acronym
- midP
- Status last verified
- Feb 2021
- First submitted
- 29 Jun 2012
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Study Evaluating the Interest of Mid-position Strategy Versus ITV (Internal Target Volume) Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-resected Non-small Cell Lung Carcinoma (NSCLC).
- ClinicalTrials.gov ID
- NCT01635270
- Acronym / sponsor ID
- midP / midP
- Conditions
- Non-small Cell Lung Cancer, Radiation Therapy, Locally Advanced Disease, Non-metastatic Disease, Non-resectable Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- CREATIS Laboratory
- Study start
- 12 Sep 2012 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 9 Jul 2012 (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 establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midP arm | Experimental | Radiation: mid-position radiation strategyPatients treated with midP radiotherapy strategy. |
| ITV arm | Active comparator | Radiation: ITVPatient treated with radiotherapy ITV strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- patient with a NSCLC, non-resected, non-metastatic including a parenchyma portion
- Age >= 18 years
- PS <=2
- CT-scan within 3 months at inclusion
- PET-scan within 3 months at inclusion
Key exclusion criteria (12 listed)
- Prior surgery for NSCLC
- NSCLC nearby pulmonary apex or strictly intra-thoracic with no intra-parenchyma portion
- Metastatic disease or N3 contralateral lymph node
- History of chest irradiation
- History of known increased intrinsic radiosensibility
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 |
|---|---|---|
| mid-position radiation strategyThe midP strategy defines the target as the time weighted average tumor position (mid-position) plus an additional margin, computed specifically for each patient, that takes into account the tumor motion in each direction. This strategy can help to safely reduce toxicity while preserving treatment efficacy | Radiation | midP arm |
| ITVThe ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion. | Radiation | ITV arm |
Primary outcome
1 year Progression Free Survival rate
Time frame: 1 year
Efficacy evaluation of the midP strategy in comparison with ITV strategy in patient with locally advanced, non-resected NSCL cancer treated with radiotherapy
3 secondary outcomes
Local tumor control rate
Time frame: 1 year and 2 years after the end of irradiation
Overall survival
Time frame: 1 year and 2 years post irradiation
To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration
Time frame: Week1; Week 2; Week3; Week4; Week5; Week6; Week7 during the radiation, then 4 weeks, 3 months; 6 months ,one year and 2 years after the irradiation beginning
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 5 Feb 2021.
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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 Léon Bérard, Lyon, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mid-position radiation strategy and ITV in people with Non-small Cell Lung Cancer and Radiation Therapy, run by Centre Leon Berard 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 14 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 5 Feb 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
1 year Progression Free Survival rate (time frame: 1 year). 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 5 Feb 2021.