ClinicalTrials.gg
CompletedNCT03471741Updated Mar 21, 2018

Intensity Modulated Radiotherapy With Concomitant Boost in 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 2018-03-21.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
451
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
3rd 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 3rd 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:

1 more — sign in →

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

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

Read the detailed description

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.

03

Conditions studied

  • Breast Cancer
  • Radiation Toxicity

Keywords

  • breast cancer
  • radiotherapy
  • cutaneous toxicity
  • subcutaneous toxicity
  • local control
  • 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-2 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 invasive breast cancer (pT1-4) with at least one of these characteristics: 3 or more axillary nodes, pre or peri-menopausal status, close resection margins
  • breast conservative surgery

Exclusion criteria

Exclusion Criteria:

  • positive margins
  • distant
Terms in these criteria, in plain language(2)

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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

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
451 participants (actual)
Patient registry
No

Groups and cohorts

  • MARA-2: IMRT with concomitant boost

    A forward planned IMRT technique was used and the prescribed dose to the whole breast was 50 Gy plus a concomitant boost of 10 Gy to the tumor bed

    Radiation: IMRT with concomitant boost

  • CG: 3D-RT with sequential boost

    The whole breast received 50.4 Gy in 28 fractions delivered with 3D-RT, followed by a sequential boost on the tumor bed of 10 Gy in 4 fractions delivered with electrons

    Radiation: 3D-RT with sequential boost

Interventions

  • RadiationIMRT with concomitant boost
  • Radiation3D-RT with sequential boost
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. Local control

    absence of locoregional relapse

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Macchia G, Cilla S, Buwenge M, Zamagni A, Ammendolia I, Zamagni C, Frezza GP, Valentini V, Deodato F, Morganti AG. Intensity-Modulated Radiotherapy with Concomitant Boost After Breast Conserving Surgery: A Phase I-II Trial. Breast Cancer (Dove Med Press). 2020 Nov 12;12:243-249. doi: 10.2147/BCTT.S261587. eCollection 2020. PubMed 33209058 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2001 to primary completion in Dec 2017, 198 months.

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

Registered
Mar 14, 2018
First posted
Mar 21, 2018
StartActual
Jun 1, 2001
Primary completionActual
Dec 31, 2017
CompletionActual
Dec 31, 2017
Last update
Mar 21, 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 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03471741
Responsible party
Alessio Giuseppe Morganti (Professor, IRCCS Azienda Ospedaliero-Universitaria di Bologna) — Principal investigator
First posted
Mar 21, 2018
Start date
Jun 1, 2001
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Mar 21, 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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