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

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Radiation: Radiotherapy by Prone and decubitus

• Registration Number: NCT02704312
• Lead Sponsor: University Hospital Center of Martinique

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).

Study Timeline

• Study Start: 2015-11-30
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Status Verified: 2021-02
• Primary Completion: 2021-08
• Study Completion: 2022-02-11
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy techniques	Radiotherapy by Prone and decubitus	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of Life Questionnaire	Baseline and Follow up month 3, 12, 24 and 36

Trial Locations

Locations (1)

CHU de Martinique; 🇲🇶 Fort de France, Martinique