Breast NeoplasmsPhase 2/3NCT01276938
Exclusive Intraoperative Radiation Therapy for Breast Cancer
A Phase 2/3 study testing 21 Gy radiation and 18 Gy radiation in people with Breast Neoplasms and Toxicity, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
Trial summary
Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy Read more about this study
- Who is it for?
- Ages 45 to 85 years, women only
- Conditions the study is for
- Breast Neoplasms, Toxicity
- What is being tested?
- 21 Gy radiation and 18 Gy radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Sep 2011
- Phase
- Phase 2/3
- 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 45 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non lobular epithelial breast carcinoma, excised with standard quadrantectomy
- Age ≥ 45 and < 85
- Tumor major diameter ≤ 2.5 cm
- Negative surgical margins (≥ 5 mm)
- Willingness to undergo follow up examinations
- Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography)
- Signed informed consent
Who cannot join
- Ductal carcinoma in situ or lobular carcinoma
- Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
- Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
- Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
- Collagen vascular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment
Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy
- Conditions
- Breast Neoplasms, Toxicity
- Being tested
- 21 Gy radiation, 18 Gy radiation
- Keywords
- Breast cancer, Intra Operative Radiation Therapy, Toxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
21 Gy radiationRadiation
21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
18 Gy radiationRadiation
18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
| Study group | Role | What they receive |
|---|---|---|
| IORT 21 Gy | Active comparator | Single fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm Receives: Radiation: 21 Gy radiation |
| IORT 18 Gy | Experimental | Single fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm. Receives: Radiation: 18 Gy radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early toxicity
Assessment of early toxicity using modified RTOG scale
Measured: 6 months
Late toxicity
Assessment of late toxicity using modified LENT scale
Measured: 5 years
Cosmetic outcome
Assessment of cosmetic outcome according to semi-objective criteria
Measured: 5 years
Secondary outcomes (2)
Local Relapse Free Survival (LRFS)
Local recurrence rate will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data
Measured: 10 years
Disease Free Survival (DFS)
Disease Free Survival will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startApr 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Marina Guenzi, MD, Principal investigator, IRCCS AOU SanMartino IST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276938
- Sponsor's protocol ID
- istgeiort
- Status last verified
- Sep 2010
- First submitted
- 13 Jan 2011
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guenzi M, Fozza A, Timon G, Belgioia L, Vidano G, Cavagnetto F, Agostinelli S, Gusinu M, Carli F, Cafiero F, Friedman D, Canavese G, Corvo R. A two-step selection of breast cancer patients candidates for exclusive IORT with electrons: a mono-institutional experience. Anticancer Res. 2012 Apr;32(4):1533-6.
PubMed 22493397Bonzano E, Belgioia L, Fregatti P, Friedman D, Agostinelli S, Cavagnetto F, Bevegni M, Corvo R, Guenzi M. Tumor Size-driven Dose of Intraoperative Radiotherapy for Breast Cancer: 18 Gy Versus 21 Gy. Anticancer Res. 2018 Sep;38(9):5475-5479. doi: 10.21873/anticanres.12880.
PubMed 30194205
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment
- ClinicalTrials.gov ID
- NCT01276938
- Acronym / sponsor ID
- istgeiort
- Conditions
- Breast Neoplasms, Toxicity
- Keywords
- Breast cancer, Intra Operative Radiation Therapy, Toxicity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Jan 2011 (estimated)
- 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.
Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IORT 21 Gy | Active comparator | Radiation: 21 Gy radiationSingle fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm |
| IORT 18 Gy | Experimental | Radiation: 18 Gy radiationSingle fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non lobular epithelial breast carcinoma, excised with standard quadrantectomy
- Age ≥ 45 and < 85
- Tumor major diameter ≤ 2.5 cm
- Negative surgical margins (≥ 5 mm)
- Willingness to undergo follow up examinations
Key exclusion criteria (5 listed)
- Ductal carcinoma in situ or lobular carcinoma
- Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
- Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
- Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
- Collagen vascular disorders
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 |
|---|---|---|
| 21 Gy radiation21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV) | Radiation | IORT 21 Gy |
| 18 Gy radiation18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV) | Radiation | IORT 18 Gy |
Primary outcome
Early toxicity
Time frame: 6 months
Assessment of early toxicity using modified RTOG scale
Late toxicity
Time frame: 5 years
Assessment of late toxicity using modified LENT scale
Cosmetic outcome
Time frame: 5 years
Assessment of cosmetic outcome according to semi-objective criteria
2 secondary outcomes
Local Relapse Free Survival (LRFS)
Time frame: 10 years
Disease Free Survival (DFS)
Time frame: 10 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 24 May 2017.
- Background: PubMed 22493397Guenzi M, Fozza A, Timon G, Belgioia L, Vidano G, Cavagnetto F, Agostinelli S, Gusinu M, Carli F, Cafiero F, Friedman D, Canavese G, Corvo R. A two-step selection of breast cancer patients candidates for exclusive IORT with electrons: a mono-institutional experience. Anticancer Res. 2012 Apr;32(4):1533-6.
- Derived from this study: PubMed 30194205Bonzano E, Belgioia L, Fregatti P, Friedman D, Agostinelli S, Cavagnetto F, Bevegni M, Corvo R, Guenzi M. Tumor Size-driven Dose of Intraoperative Radiotherapy for Breast Cancer: 18 Gy Versus 21 Gy. Anticancer Res. 2018 Sep;38(9):5475-5479. doi: 10.21873/anticanres.12880.
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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.
Marina Guenzi, MD principal investigator
IRCCS AOU SanMartino IST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 21 Gy radiation and 18 Gy radiation in people with Breast Neoplasms and Toxicity, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
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 7 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Early toxicity (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT01276938, which also lists 2 linked publications.
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 24 May 2017.