OncologyMUMOFRATNCT03175861
Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation
An observational study of Oncology, run by University Hospital, Brest at 4 sites in France.
Trial summary
Identify 18-Fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) parameters predictive of tumor response and local control Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Stereotactic radiotherapy
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Jun 2017to Jun 2020
- Phase
- Observational
- 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
Study population: All major patients requiring stereotactic radiotherapy for non-small cell bronchopulmonary carcinoma.
Who may be able to join
- Age> 18 years
- Performance Index WHO (World Health Organization) ≤ 2
- Bronchopulmonary carcinoma not in small cells proved histologically or cytologically (epidermoid, adenocarcinoma, or large cell carcinoma).
- Tumor classified T1 - T2 (Tumor=1-2) N0 (Node=0) M0 (Metastasis=0) and diameter ≤ 5 cm or Tumor classified T3 (≤5cm) N0M0 of the chest wall
- Tumor located more than 2 cm from the trachea and bronchus stem and more than 1.5 cm from the organs at risk
- Medically inoperable or refusing surgery
- Indication of stereotactic radiotherapy validated in multidisciplinary consultation meeting
- Formulation of consent
Who cannot join
- Age <18 years.
- History of pulmonary irradiation
- Pulmonary surgery of the tumor
- Different histology of non-small cell carcinoma
- Patient with a T2 or T3> 5 cm tumor or patients with a T3 tumor invading a structure other than the chest wall
- Patient with a tumor within 2 cm of the trachea and bronchus stem and within 1.5 cm of the organs at risk in the proximal area of the no fly zone (defined as a volume Located 2 cm in all directions of the proximal bronchial tree - Pulmonary metastases
Show all 12Show fewer
- Declared pregnancy, breast-feeding
- Refusal to use effective contraception
- Against indication to the realization of the PET to the 18FDG (18-fluorodeoxyglucose)(uncontrolled diabetes)
- Refusal or inability to consent to participate in the study.
- Estimated life expectancy <2 months in the absence of treatment
- Other invasive tumors diagnosed in the previous 2 years, with the exception of non-melanocytic cutaneous carcinomas.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 3 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Ulrike Schick, Doctor, 0298223398 ext. +33, ulrike.schick@chu-brest.fr
- Recruiting
Centre Eugène Marquis
Rennes, 35042
Enrique Chajon, +33(0)2 99 25 30 92, e.chajon@rennes.unicancer.fr
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Marc André Mahé, +33(0)2 40 67 99 00, marc-andre.mahe@ico.unicancer.fr
- Completed
Clinique d'Oncologie et Radiothérapie
Tours, 37000
About this study
Official title: Multiscale Modeling / Simulation of the Response to Pulmonary Stereotactic Hypofractionated Irradiation
Identify 18-Fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) parameters predictive of tumor response and local control
Read the detailed description
The identification of robust prognostic and predictive markers could allow the individualization of pulmonary stereotactic radiotherapy treatments and the selection of patients at high risk of relapse, who could then benefit from a dose escalation in order to increase the chances of local control .
Beyond the pulmonary RTS (Radiotherapy in stereotactic condition), this study will aim to generate one or more models of multi-scale response to hypofractionated irradiation from biomarkers (biological or images) extracted from preclinical or clinical literature data and to allow simulations of Various modified fractionation irradiation schemes, potentially leading to new regimens that reduce side effects and increase therapeutic efficacy.
- Conditions
- Oncology
- Being tested
- Stereotactic radiotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapyOther
The patient will have an initial pre-therapeutic assessment in the 8 weeks before the start of radiotherapy Then, radiation therapy planning with 3 free breathing 4D (4 dimensions) scanners performed over 8 days without injection of iodinated contrast agent.
Then the patient will receive his treatment by conventional stereotactic radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetics of PET-CT parameters : standardized uptake value (SUV) max
SUV max will be measured before and after stereotactic irradiation.
Measured: 2 years
Tumor metabolic response
Tumor metabolic response, as assessed on 18F-FDG PET-CT at 6 months of end of radiotherapy
Measured: 2 years
Local control
Local control defined by the absence of progression in the irradiated area
Measured: 2 years
Kinetics of PET-CT parameters : metabolic tumor volume
Metabolic tumor volume (MTV) will be measured before and after stereotactic irradiation.
Measured: 2 years
Kinetics of PET-CT parameters : texture parameters :quantitative extraction of images by specific software
The first-order form parameters and statistical parameters, the second order (based on the matrix of co-occurrence of the grey levels and the matrix of differences of grey levels) and of the third order (based on the matrices of alignment of the grey levels and the matrices of sizes of zones) will be studied.
Measured: 2 years
Secondary outcomes (7)
Kinetics of serum markers
The kinectic will be measured
Measured: 2 years
Predictive power of serum markers for tumor response and local control
This predictive power will be measured
Measured: 2 years
Predictive power of metabolic imaging parameters for tumor response and local control Predictive power of metabolic imaging parameters for tumor response and local control
This predictive power will be measured
Measured: 2 years
Correlation between these parameters
The correlation will be measured
Measured: 2 years
Survival in disease
The survival in desease will be observed
Measured: 2 years
Survival without metastasis at a distance
The survival without metastasis will be observed
Measured: 2 years
Radiation-induced toxicity
The radiation-induced toxicity will be observed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start14 Jun 2017
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrike Schick, Doctor, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175861
- Sponsor's protocol ID
- MUMOFRAT
- Acronym
- MUMOFRAT
- Status last verified
- Oct 2018
- First submitted
- 23 May 2017
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiscale Modeling / Simulation of the Response to Pulmonary Stereotactic Hypofractionated Irradiation
- ClinicalTrials.gov ID
- NCT03175861
- Acronym / sponsor ID
- MUMOFRAT / MUMOFRAT
- Conditions
- Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 5 Jun 2017 (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.
Identify 18-Fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) parameters predictive of tumor response and local control
Detailed description
The identification of robust prognostic and predictive markers could allow the individualization of pulmonary stereotactic radiotherapy treatments and the selection of patients at high risk of relapse, who could then benefit from a dose escalation in order to increase the chances of local control .
Beyond the pulmonary RTS (Radiotherapy in stereotactic condition), this study will aim to generate one or more models of multi-scale response to hypofractionated irradiation from biomarkers (biological or images) extracted from preclinical or clinical literature data and to allow simulations of Various modified fractionation irradiation schemes, potentially leading to new regimens that reduce side effects and increase therapeutic efficacy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All major patients requiring stereotactic radiotherapy for non-small cell bronchopulmonary carcinoma.
Key inclusion criteria (8 listed)
- Age> 18 years
- Performance Index WHO (World Health Organization) ≤ 2
- Bronchopulmonary carcinoma not in small cells proved histologically or cytologically (epidermoid, adenocarcinoma, or large cell carcinoma).
- Tumor classified T1 - T2 (Tumor=1-2) N0 (Node=0) M0 (Metastasis=0) and diameter ≤ 5 cm or Tumor classified T3 (≤5cm) N0M0 of the chest wall
- Tumor located more than 2 cm from the trachea and bronchus stem and more than 1.5 cm from the organs at risk
Key exclusion criteria (12 listed)
- Age <18 years.
- History of pulmonary irradiation
- Pulmonary surgery of the tumor
- Different histology of non-small cell carcinoma
- Patient with a T2 or T3> 5 cm tumor or patients with a T3 tumor invading a structure other than the chest wall
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 radiotherapyThe patient will have an initial pre-therapeutic assessment in the 8 weeks before the start of radiotherapy Then, radiation therapy planning with 3 free breathing 4D (4 dimensions) scanners performed over 8 days without injection of iodinated contrast agent. Then the patient will receive his treatment by conventional stereotactic radiotherapy | Other | – |
Primary outcome
Kinetics of PET-CT parameters : standardized uptake value (SUV) max
Time frame: 2 years
SUV max will be measured before and after stereotactic irradiation.
Tumor metabolic response
Time frame: 2 years
Tumor metabolic response, as assessed on 18F-FDG PET-CT at 6 months of end of radiotherapy
Local control
Time frame: 2 years
Local control defined by the absence of progression in the irradiated area
Kinetics of PET-CT parameters : metabolic tumor volume
Time frame: 2 years
Metabolic tumor volume (MTV) will be measured before and after stereotactic irradiation.
Kinetics of PET-CT parameters : texture parameters :quantitative extraction of images by specific software
Time frame: 2 years
The first-order form parameters and statistical parameters, the second order (based on the matrix of co-occurrence of the grey levels and the matrix of differences of grey levels) and of the third order (based on the matrices of alignment of the grey levels and the matrices of sizes of zones) will be studied.
7 secondary outcomes
Kinetics of serum markers
Time frame: 2 years
Predictive power of serum markers for tumor response and local control
Time frame: 2 years
Predictive power of metabolic imaging parameters for tumor response and local control Predictive power of metabolic imaging parameters for tumor response and local control
Time frame: 2 years
Correlation between these parameters
Time frame: 2 years
Survival in disease
Time frame: 2 years
Survival without metastasis at a distance
Time frame: 2 years
Radiation-induced toxicity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
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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.
Ulrike Schick, Doctor principal investigator
University Hospital, Brest
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by University Hospital, Brest at 4 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 8 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: status not confirmed, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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 Ulrike Schick, Doctor (0298223398 ext. +33, ulrike.schick@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics of PET-CT parameters : standardized uptake value (SUV) max (time frame: 2 years). The study lists 5 primary outcomes in all. 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 19 Oct 2018.