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Completed

NCT Number: NCT03461224

Modulated Accelerated RAdiotherapy in Early Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Radiation Toxicity Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

accelerated hypofractionated RT

Radiation

conventional fractionated RT

Radiation

Primary outcomes

  1. Incidence of treatment-related late adverse events

    Time frame: 5 years

    late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients

Secondary outcomes

  1. Incidence of treatment-related acute adverse events

    Time frame: 6 months

    acute toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients

  2. local control

    Time frame: 5 years

    absence of locoregional relapse

  3. overall survival

    Time frame: 5 years

    defined as the time from diagnosis to death

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2018
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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