Modulated Accelerated RAdiotherapy in Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

Postoperative Modulated Accelerated RAdiotherapy (MARA-1) for Early Stage Breast Cancer: a Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461224
• Other study ID #: MARA-1
• Status: Completed
• Phase: N/A
• First received: March 5, 2018
• Last updated: March 9, 2018
• Start date: January 10, 2001
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial was a retrospective study on postoperative accelerated hypofractionated IMRT (MARA-1) in patients with early stage breast carcinoma, to compare late toxicity after this treatment and standard fractionated RT delivered with 3D-CRT.

Description:

The aim of this study was to evaluate the clinical results in terms of late skin and subcutaneous toxicity of accelerated hypofractionated forward-planned IMRT in patients with early stage BC. Results were compared with a historical control group (CG) of patients treated with 3D-conformal postoperative RT delivered with conventional fractionation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• confirmed histologic evidence of pTis-pT3 breast cancer

• breast conservative surgery

• post menopausal status

• clear surgical margin

Exclusion Criteria:

• pT4

• positive or close resection margins

• 3 or more metastatic axillary nodes

• nodal irradiation

• M1

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiation Toxicity

Intervention

Radiation:
• accelerated hypofractionated RT

• conventional fractionated RT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-related late adverse events	late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients	5 years
Secondary	Incidence of treatment-related acute adverse events	acute toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients	6 months
Secondary	local control	absence of locoregional relapse	5 years
Secondary	overall survival	defined as the time from diagnosis to death	5 years