Breast CancerPhase 2NCT01008514
Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
A Phase 2 study testing adjuvant therapy, accelerated partial breast irradiation and intracavitary balloon brachytherapy in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center.
Trial summary
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- adjuvant therapy, accelerated partial breast irradiation and intracavitary balloon brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive breast adenocarcinoma
- Stage 0, I, or II (T2, N0; tumor size ≤ 3 cm) disease
- Pathologic staging of the axilla preferred
- Clinical staging of the axilla allowed for patients ≥ 70 years of age with hormone receptor-positive tumors
- Unicentric tumor
- Microscopic multifocality allowed as long as the total tumor size is ≤ 3 cm
- Must have undergone lumpectomy as definitive surgery
- Negative surgical margins, defined as no tumor at the inked margin of resection after final surgery
- Re-excision to obtain negative margins allowed
- Must have adequate skin spacing between balloon surface and surface of the skin and lung (≥ 7 mm)
- No multicentric carcinoma (invasive or DCIS) in more than one quadrant
- No clinically or pathologically positive regional lymph nodes
- No extensive intraductal component, defined as DCIS extending beyond the primary invasive component into normal breast parenchyma and composing > 25% of the primary tumor
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No collagen-vascular disease, including any of the following:
- Dermatomyositis
- Systemic lupus erythematosus
- Scleroderma-mixed connective tissue disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.
Secondary
- To assess the toxicities associated with MammoSite® RTS in these patients.
- To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
- To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
- To correlate the local recurrence rate with time between surgery and implant.
OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device into the cavity where the tumor was removed either at the time of surgery or percutaneously under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.
After completion of study therapy, patients are followed up periodically for 5 years.
- Conditions
- Breast Cancer
- Being tested
- adjuvant therapy, accelerated partial breast irradiation, intracavitary balloon brachytherapy
- Keywords
- ductal breast carcinoma in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant therapyProcedure or surgery
accelerated partial breast irradiationRadiation
intracavitary balloon brachytherapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of local recurrence
- Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume.
- Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume.
Measured: up to 5 years
Secondary outcomes (2)
Safety and toxicity
Measured: up to 30 months after radiotherapy
Cosmetic results
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
Why it stopped: funding issues and Principal Investigator leaving the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Kim, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008514
- Sponsor's protocol ID
- OSU-08177
- Status last verified
- Mar 2015
- First submitted
- 4 Nov 2009
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
- ClinicalTrials.gov ID
- NCT01008514
- Acronym / sponsor ID
- OSU-08177
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding issues and Principal Investigator leaving the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- First posted
- 5 Nov 2009 (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.
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.
Detailed description
OBJECTIVES:
Primary
- To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.
Secondary
- To assess the toxicities associated with MammoSite® RTS in these patients.
- To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
- To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
- To correlate the local recurrence rate with time between surgery and implant.
OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device into the cavity where the tumor was removed either at the time of surgery or percutaneously under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.
After completion of study therapy, patients are followed up periodically for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| adjuvant therapy | Procedure or surgery | – |
| accelerated partial breast irradiation | Radiation | – |
| intracavitary balloon brachytherapy | Radiation | – |
Primary outcome
Proportion of local recurrence
Time frame: up to 5 years
* Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume. * Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume.
2 secondary outcomes
Safety and toxicity
Time frame: up to 30 months after radiotherapy
Cosmetic results
Time frame: up to 30 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- JameslineLink provided by the sponsor.
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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.
Edward Kim, MD principal investigator
Ohio State University Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adjuvant therapy, accelerated partial breast irradiation and intracavitary balloon brachytherapy in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 26 Mar 2015. 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of local recurrence (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2015.