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

• Sponsor: University Hospital Center of Martinique (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02704312
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 74.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: Radiotherapy by Prone and decubitus	N/A

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

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Feasibility Study of Patient Comfort and Dosimetry Evaluation in Prone Breast Radiotherapy.
• Actual Study Start Date: Nov 30, 2015
• Actual Primary Completion Date: Aug 1, 2021
• Actual Study Completion Date: Feb 11, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk [From baseline to 5 weeks]

Secondary Outcome Measures

1. Quality of Life Questionnaire [Baseline and Follow up month 3, 12, 24 and 36]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Martinique	Fort de France		Martinique

Sponsors and Collaborators

• University Hospital Center of Martinique

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Center of Martinique
• ClinicalTrials.gov Identifier: NCT02704312
• Other Study ID Numbers: 15/ B/ 25
• First Posted: Mar 10, 2016
• Last Update Posted: Mar 8, 2022
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Mar 8, 2022