Dosimetric Comparison of Doses in Both Positions (Prone and Decubitus) for Patient With Breast Cancer (PROCUBITUS)

February 21, 2022 updated by: University Hospital Center of Martinique

A Feasibility Study of Patient Comfort and Dosimetry Evaluation in Prone Breast Radiotherapy.

Compare dosimeters in both positions (prone and decubitus) for each patient

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Martinique
      • Fort de France, Martinique
        • CHU de Martinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Radiotherapy techniques
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)
Radiation: Radiotherapy by Prone and decubitus
Dosimetric comparison of doses in target volumes and organs at risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk
Time Frame: From baseline to 5 weeks
From baseline to 5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life Questionnaire
Time Frame: Baseline and Follow up month 3, 12, 24 and 36
Baseline and Follow up month 3, 12, 24 and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Center of Martinique

Investigators

  • Principal Investigator: Vincent VINH HUNG, MD, CHU de Martinique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2015

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ACTUAL)

February 11, 2022

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (ESTIMATE)

March 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/ B/ 25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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