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OpenTrials
Completed

NCT Number: NCT03471741

Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer

To assess feasibility of postoperative IMRT with concomitant boost in moderate-high risk breast cancer in terms of late toxicity and local control

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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

Patients treated conservatively with moderate-high risk breast cancer were treated with IMRT plus concomitant boost to surgical bed (up to a dose of 50 Gy to whole breast and 60 Gy to the tumor bed).

Aim of the study was to evaluate late toxicity and local control after this treatment compared with a historical control group (CG) of patients treated with 3D-conformal postoperative radiotherapy delivered with conventional fractionation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • histologically confirmed invasive breast cancer (pT1-4) with at least one of these characteristics: 3 or more metastatic axillary nodes, pre or peri-menopausal status, close resection margins
  • breast conservative surgery

Exclusion criteria

  • positive margins
  • distant metastases

Treatment and study plan

IMRT with concomitant boost

Radiation

3D-RT with sequential boost

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. Local control

    Time frame: 5 years

    absence of locoregional relapse

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Moderated Accelerated RAdiotherapy (MARA-2) in Moderate-high Risk Breast Cancer: a Phase I-II Study

Important dates

Study start
2001
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2018
Registry last updated
Mar 21, 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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