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CompletedNCT03461224Updated Mar 12, 2018

Modulated Accelerated RAdiotherapy in Early Breast Cancer

An observational study in Breast Cancer and Radiation Toxicity, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2018-03-12.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
447
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Breast Neoplasms by IRCCS Azienda Ospedaliero-Universitaria di Bologna — 6 open to participants now, 8 under way, none of them phase 3. Breast Neoplasms · IRCCS Azienda Ospedaliero-Universitaria di Bologna.

Started
2001
with 1 other
Observational
8 of 12
5 open now
Registered
2nd of 12
by date

Among the 12 studies in Breast Neoplasms by IRCCS Azienda Ospedaliero-Universitaria di Bologna, this one is one of 2 that started in 2001, is one of 8 observational ones, and was the 2nd registered.

Breast Neoplasms

14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

6 of the 12 studies in Breast Neoplasms by IRCCS Azienda Ospedaliero-Universitaria di Bologna are open now, in 1 country. Recruiting first, the newest first:

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By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: female · no healthy volunteers.

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02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Breast Cancer
  • Radiation Toxicity

Keywords

  • breast cancer
  • radiotherapy
  • cutaneous toxicity
  • subcutaneous toxicity
  • IMRT
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

From 2003, all women fullfilling the inclusion criteria were treated with MARA-1 scheme

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed histologic evidence of pTis-pT3 breast cancer
  • breast conservative surgery
  • post menopausal status
  • clear surgical margin

Exclusion criteria

Exclusion Criteria:

  • pT4
  • positive or close resection margins
  • 3 or more axillary nodes
  • nodal irradiation
  • M1
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
447 participants (actual)
Patient registry
No

Groups and cohorts

  • MARA-1: accelerated hypofractionated RT

    A forward planned IMRT technique was used and the prescribed dose to the breast was 40 Gy in 16 fx with a concomitant boost of 4 Gy.

    Radiation: accelerated hypofractionated RT

  • CG: conventional fractionated RT

    In the CG, the whole breast received 50.4 Gy in 28 fractions (fx) delivered with 3D-RT, followed by a sequential boost on the tumour bed of 10 Gy in 4 fx delivered with electrons

    Radiation: conventional fractionated RT

Interventions

  • Radiationaccelerated hypofractionated RT
  • Radiationconventional fractionated RT
06

What researchers measure

Primary outcomes

  1. Incidence of treatment-related late adverse events

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

    Time frame: 5 years

Secondary outcomes

  1. Incidence of treatment-related acute adverse events

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

    Time frame: 6 months

  2. local control

    absence of locoregional relapse

    Time frame: 5 years

  3. overall survival

    defined as the time from diagnosis to death

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Digesu C, Deodato F, Macchia G, Cilla S, Pieri M, Zamagni A, Farioli A, Buwenge M, Ferrandina G, Morganti AG. Hypofractionated radiotherapy after conservative surgery may increase low-intermediate grade late fibrosis in breast cancer patients. Breast Cancer (Dove Med Press). 2018 Oct 3;10:143-151. doi: 10.2147/BCTT.S167914. eCollection 2018. PubMed 30323658 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2001 to primary completion in Dec 2017, 203 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Mar 9, 2018
StartActual
Jan 10, 2001
Primary completionActual
Dec 31, 2017
CompletionActual
Dec 31, 2017
Last update
Mar 12, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03461224
Responsible party
Alessio Giuseppe Morganti (Professor, IRCCS Azienda Ospedaliero-Universitaria di Bologna) — Principal investigator
First posted
Mar 9, 2018
Start date
Jan 10, 2001
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Mar 12, 2018

Study contacts

Alessio G. Morganti, MD
principal investigator · Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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