Breast CancerNCT03461224
Modulated Accelerated RAdiotherapy in Early Breast Cancer
An observational study of Breast Cancer and Radiation Toxicity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Radiation Toxicity
- What is being tested?
- accelerated hypofractionated RT and conventional fractionated RT
- Type of treatment
- Surgery or procedure
- How many people
- 447 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2001to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: From 2003, all women fullfilling the inclusion criteria were treated with MARA-1 scheme
Who may be able to join
- confirmed histologic evidence of pTis-pT3 breast cancer
- breast conservative surgery
- post menopausal status
- clear surgical margin
Who cannot join
- pT4
- positive or close resection margins
- 3 or more metastatic axillary nodes
- nodal irradiation
- M1
About this study
Official title: Postoperative Modulated Accelerated RAdiotherapy (MARA-1) for Early Stage Breast Cancer: a Retrospective Analysis
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.
- Conditions
- Breast Cancer, Radiation Toxicity
- Being tested
- accelerated hypofractionated RT, conventional fractionated RT
- Keywords
- breast cancer, radiotherapy, cutaneous toxicity, subcutaneous toxicity, IMRT
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelerated hypofractionated RTRadiation
conventional fractionated RTRadiation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Radiation: conventional fractionated RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related late adverse events
late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients
Measured: 5 years
Secondary outcomes (3)
Incidence of treatment-related acute adverse events
acute toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients
Measured: 6 months
local control
absence of locoregional relapse
Measured: 5 years
overall survival
defined as the time from diagnosis to death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start10 Jan 2001
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461224
- Sponsor's protocol ID
- MARA-1
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Modulated Accelerated RAdiotherapy (MARA-1) for Early Stage Breast Cancer: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03461224
- Acronym / sponsor ID
- MARA-1
- Conditions
- Breast Cancer, Radiation Toxicity
- Keywords
- breast cancer, radiotherapy, cutaneous toxicity, subcutaneous toxicity, IMRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 10 Jan 2001 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MARA-1: accelerated hypofractionated RT | – | Radiation: accelerated hypofractionated RTA 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. |
| CG: conventional fractionated RT | – | Radiation: conventional fractionated RTIn 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From 2003, all women fullfilling the inclusion criteria were treated with MARA-1 scheme
Key inclusion criteria (4 listed)
- confirmed histologic evidence of pTis-pT3 breast cancer
- breast conservative surgery
- post menopausal status
- clear surgical margin
Key exclusion criteria (5 listed)
- pT4
- positive or close resection margins
- 3 or more metastatic axillary nodes
- nodal irradiation
- M1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| accelerated hypofractionated RT | Radiation | MARA-1: accelerated hypofractionated RT |
| conventional fractionated RT | Radiation | CG: conventional fractionated RT |
Primary outcome
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
3 secondary outcomes
Incidence of treatment-related acute adverse events
Time frame: 6 months
local control
Time frame: 5 years
overall survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Derived from this study: PubMed 30323658Digesu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Radiation Toxicity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related late adverse events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03461224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.