Breast CancerPROCUBITUSNCT02704312
Dosimetric Comparison of Doses in Both Positions (Prone and Decubitus) for Patient With Breast Cancer
A study testing Radiotherapy by Prone and decubitus in people with Breast Cancer, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
Compare dosimeters in both positions (prone and decubitus) for each patient Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiotherapy by Prone and decubitus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteMartinique
- Study dates
- 30 Nov 2015to 11 Feb 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary breast cancer and in whom conservative post- surgery radiation therapy for breast cancer is prescribed.
- Patients aged over 18 years
- Patients with indication for conservative surgery.
- Resection should be in healthy margin.
- Women of childbearing potential must satisfy a negative pregnancy test at the screening visit and use effective contraception as determined by the physician of the patient throughout the study.
Who cannot join
- Minor Patient
- Patients whose tumor resection is incomplete
- Patients with an indication of mastectomy
- Patients with a history of radiation therapy of the chest
- Pregnant women, lactating, or of childbearing age without effective contraception.
- Patients who had more than 4 scanners in one year. ( Scanner cervical , thoracic, or abdominal
- Patients with an incompatible condition with monitoring protocol (psychiatric disorder, uncontrolled disease).
- Patient unable to respond to a questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Patient Comfort and Dosimetry Evaluation in Prone Breast Radiotherapy.
Compare dosimeters in both positions (prone and decubitus) for each patient
Read the detailed description
Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk. The technique used is that of which the dose on the organs at risk is as low as possible, and whose dose to the target volume is the closest possible to the prescribed dose (100% of the prescribed dose).
- Conditions
- Breast Cancer
- Being tested
- Radiotherapy by Prone and decubitus
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy by Prone and decubitusRadiation
Dosimetric comparison of doses in target volumes and organs at risk
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy techniques | Experimental | Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk. The technique used is that of which the dose on the organs at risk is as low as possible, and whose dose to the target volume is the closest possible to the prescribed dose (100% of the prescribed dose) Receives: Radiation: Radiotherapy by Prone and decubitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk
Measured: From baseline to 5 weeks
Secondary outcomes (1)
Quality of Life Questionnaire
Measured: Baseline and Follow up month 3, 12, 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start30 Nov 2015
- Primary completionAug 2021
- Study completion11 Feb 2022
Why it stopped: Start of the Principal Investigatoir
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent VINH HUNG, MD, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704312
- Sponsor's protocol ID
- 15/ B/ 25
- Acronym
- PROCUBITUS
- Status last verified
- Feb 2021
- First submitted
- 1 Mar 2016
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Patient Comfort and Dosimetry Evaluation in Prone Breast Radiotherapy.
- ClinicalTrials.gov ID
- NCT02704312
- Acronym / sponsor ID
- PROCUBITUS / 15/ B/ 25
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Start of the Principal Investigatoir
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- Aug 2021 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 10 Mar 2016 (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.
Compare dosimeters in both positions (prone and decubitus) for each patient
Detailed description
Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk. The technique used is that of which the dose on the organs at risk is as low as possible, and whose dose to the target volume is the closest possible to the prescribed dose (100% of the prescribed dose).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy techniques | Experimental | Radiation: Radiotherapy by Prone and decubitusQuantitative Physics: dosimetric comparison of doses in target volumes and organs at risk. The technique used is that of which the dose on the organs at risk is as low as possible, and whose dose to the target volume is the closest possible to the prescribed dose (100% of the prescribed dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with primary breast cancer and in whom conservative post- surgery radiation therapy for breast cancer is prescribed.
- Patients aged over 18 years
- Patients with indication for conservative surgery.
- Resection should be in healthy margin.
- Women of childbearing potential must satisfy a negative pregnancy test at the screening visit and use effective contraception as determined by the physician of the patient throughout the study.
Key exclusion criteria (8 listed)
- Minor Patient
- Patients whose tumor resection is incomplete
- Patients with an indication of mastectomy
- Patients with a history of radiation therapy of the chest
- Pregnant women, lactating, or of childbearing age without effective contraception.
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 |
|---|---|---|
| Radiotherapy by Prone and decubitusDosimetric comparison of doses in target volumes and organs at risk | Radiation | Radiotherapy techniques |
Primary outcome
Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk
Time frame: From baseline to 5 weeks
1 secondary outcome
Quality of Life Questionnaire
Time frame: Baseline and Follow up month 3, 12, 24 and 36
Results and safety
The study was stopped early (reason given: Start of the Principal Investigatoir). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Vincent VINH HUNG, MD principal investigator
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy by Prone and decubitus in people with Breast Cancer, run by University Hospital Center of Martinique at 1 site in Martinique.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Mar 2022. 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 Martinique. 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?
The study was stopped early (reason given: Start of the Principal Investigatoir). Results are not available in the source record.
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?
Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk (time frame: From baseline to 5 weeks). 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 8 Mar 2022.