Back to resultsDosimetric Comparison of Doses in Both Positions (Prone and Decubitus) for Patient With Breast Cancer (PROCUBITUS)
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
Martinique
Study Type
Interventional
Intervention
Radiotherapy by Prone and decubitus
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- CHU de Martinique
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiotherapy techniques
Arm 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)
Outcomes
Primary Outcome Measures
Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk
Secondary Outcome Measures
Quality of Life Questionnaire
Full Information
NCT ID
NCT02704312
First Posted
March 1, 2016
Last Updated
February 21, 2022
Sponsor
University Hospital Center of Martinique
1. Study Identification
Unique Protocol Identification Number
NCT02704312
Brief Title
Dosimetric Comparison of Doses in Both Positions (Prone and Decubitus) for Patient With Breast Cancer
Acronym
PROCUBITUS
Official Title
A Feasibility Study of Patient Comfort and Dosimetry Evaluation in Prone Breast Radiotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Start of the Principal Investigatoir
Study Start Date
November 30, 2015 (Actual)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
February 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy techniques
Arm Type
Experimental
Arm 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)
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy by Prone and decubitus
Intervention Description
Dosimetric comparison of doses in target volumes and organs at risk
Primary Outcome Measure Information:
Title
Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk
Time Frame
From baseline to 5 weeks
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire
Time Frame
Baseline and Follow up month 3, 12, 24 and 36
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent VINH HUNG, MD
Organizational Affiliation
CHU de Martinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Martinique
City
Fort de France
Country
Martinique
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dosimetric Comparison of Doses in Both Positions (Prone and Decubitus) for Patient With Breast Cancer
We'll reach out to this number within 24 hrs