Breast CancerPhase 2NCT00499057
Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
A Phase 2 study testing interstitial high dose-rate brachytherapy, PBI in people with Breast Cancer, run by University Of Perugia at 1 site in Italy.
Trial summary
Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- interstitial high dose-rate brachytherapy, PBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2003to Aug 2016
- Phase
- Phase 2
- 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 40 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 40 years
- ECOG performance status 0-2
- T dimensions ≤ 2.5 cm
- Negative surgical margins
- Negative axillary lymph nodes
- Suitable breast anatomy for implantation
Who cannot join
- Age < 40 years
- ECOG performance status > 2
- T dimensions > 2.5
- Positive surgical margins
- Positive axillary lymph node
- Infiltrating lobular histology
Show all 11Show fewer
- Significant areas of lobular carcinoma in situ
- Paget's disease of the nipple
- Extensive intraductal component (EIC)
- Lymphovascular invasion
- Multifocality (n) skin infiltration
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Radiation Oncology Institute
Perugia, Perugia, 06122
Cynthia Aristei, Prof. M.D., 00390755784306, cynthia.aristei@unipg.it
Cynthia Aristei, Prof. M.D.
About this study
Official title: Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer: Results of Phase II Prospective Study
Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In our phase II prospective study PBI is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4 days (total dose 32 Gy).
Read the detailed description
Patients included in our phase II trial of PBI with interstitial HDR brachytherapy are at low-risk of relapse. Implants are positioned during surgery or postoperatively, within 12 weeks. Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy. Before post-operative implantation, all patients undergo a breast computed tomography (CT) scan to visualize and expand the excision cavity and obtain the planning target volume (PTV), i.e. the lumpectomy cavity plus a margin of 1-2 cm around it. Through virtual simulation with a 3D treatment planning system (TPS), we define the implant catheter position. After implantation, in all patients a breast CT scan checked implant geometry. On CT images transferred to a TPS the surgical cavity is outlined and expanded, the PTV defined, and inactive and active source lengths measured.CT-based 3D software is used to identify and reconstruct the catheters, outline and expand the surgical cavity and obtain the PTV. Dwell positions are activated for each catheter, and inactive and active lengths defined.Prescribed dose was 85% of the basal dose. Dwell weights are optimised in the basal points applying the volume and distance method and best values were chosen independently of strategy. A dose-volume histogram that records the volume covered by 100% and 150% of the prescribed dose (V100 and V150) was obtained for each patient. DHI, defined as V150 - V100/ V100 (7), is recognized as the most suitable quality index.
- Conditions
- Breast Cancer
- Being tested
- interstitial high dose-rate brachytherapy, PBI
- Keywords
- early stage breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interstitial high dose-rate brachytherapy, PBIRadiation
Single arm study Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy.
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Other | single arm study Receives: Radiation: interstitial high dose-rate brachytherapy, PBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer related deaths
Measured: 6 months
local relapses
Measured: 6 months
Secondary outcomes (3)
quality of life
Measured: 6 months
cosmetic results
Measured: 6 months
toxicity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startAug 2003
- Primary completionAug 2015 (estimated)
- Study completionAug 2016 (estimated)
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Aristei, University Of Perugia
- Investigators
- Cynthia Aristei, Prof. M.D., Study director, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499057
- Sponsor's protocol ID
- BRT-HDR
- Status last verified
- Jun 2010
- First submitted
- 9 Jul 2007
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Aristei C, Palumbo I, Capezzali G, Farneti A, Bini V, Falcinelli L, Margaritelli M, Lancellotta V, Zucchetti C, Perrucci E. Outcome of a phase II prospective study on partial breast irradiation with interstitial multi-catheter high-dose-rate brachytherapy. Radiother Oncol. 2013 Aug;108(2):236-41. doi: 10.1016/j.radonc.2013.08.005. Epub 2013 Sep 14.
PubMed 24044802
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer: Results of Phase II Prospective Study
- ClinicalTrials.gov ID
- NCT00499057
- Acronym / sponsor ID
- BRT-HDR
- Conditions
- Breast Cancer
- Keywords
- early stage breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 11 Jul 2007 (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.
Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In our phase II prospective study PBI is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4 days (total dose 32 Gy).
Detailed description
Patients included in our phase II trial of PBI with interstitial HDR brachytherapy are at low-risk of relapse. Implants are positioned during surgery or postoperatively, within 12 weeks. Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy. Before post-operative implantation, all patients undergo a breast computed tomography (CT) scan to visualize and expand the excision cavity and obtain the planning target volume (PTV), i.e. the lumpectomy cavity plus a margin of 1-2 cm around it. Through virtual simulation with a 3D treatment planning system (TPS), we define the implant catheter position. After implantation, in all patients a breast CT scan checked implant geometry. On CT images transferred to a TPS the surgical cavity is outlined and expanded, the PTV defined, and inactive and active source lengths measured.CT-based 3D software is used to identify and reconstruct the catheters, outline and expand the surgical cavity and obtain the PTV. Dwell positions are activated for each catheter, and inactive and active lengths defined.Prescribed dose was 85% of the basal dose. Dwell weights are optimised in the basal points applying the volume and distance method and best values were chosen independently of strategy. A dose-volume histogram that records the volume covered by 100% and 150% of the prescribed dose (V100 and V150) was obtained for each patient. DHI, defined as V150 - V100/ V100 (7), is recognized as the most suitable quality index.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Other | Radiation: interstitial high dose-rate brachytherapy, PBIsingle arm study |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > or = 40 years
- ECOG performance status 0-2
- T dimensions ≤ 2.5 cm
- Negative surgical margins
- Negative axillary lymph nodes
Key exclusion criteria (11 listed)
- Age < 40 years
- ECOG performance status > 2
- T dimensions > 2.5
- Positive surgical margins
- Positive axillary lymph node
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 |
|---|---|---|
| interstitial high dose-rate brachytherapy, PBISingle arm study Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy. | Radiation | single arm study |
Primary outcome
cancer related deaths
Time frame: 6 months
local relapses
Time frame: 6 months
3 secondary outcomes
quality of life
Time frame: 6 months
cosmetic results
Time frame: 6 months
toxicity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Derived from this study: PubMed 24044802Aristei C, Palumbo I, Capezzali G, Farneti A, Bini V, Falcinelli L, Margaritelli M, Lancellotta V, Zucchetti C, Perrucci E. Outcome of a phase II prospective study on partial breast irradiation with interstitial multi-catheter high-dose-rate brachytherapy. Radiother Oncol. 2013 Aug;108(2):236-41. doi: 10.1016/j.radonc.2013.08.005. Epub 2013 Sep 14.
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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.
Cynthia Aristei, Prof. M.D. study director
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interstitial high dose-rate brachytherapy, PBI in people with Breast Cancer, run by University Of Perugia 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Dec 2014. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Aristei, Prof. M.D. (00390755784306, cynthia.aristei@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cancer related deaths (time frame: 6 months). The study lists 2 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 NCT00499057, 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 23 Dec 2014.