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RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.
PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.
OBJECTIVES:
OUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.
All patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity.
Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative radiation therapy | Experimental | Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed. |
|
| Intracavitary balloon brachytherapy | Experimental | Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intracavitary balloon brachytherapy | Radiation | Patients undergo brachytherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | 1 month after radiation therapy (RT) |
| Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | 3 months after RT |
| Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | 6 months after RT |
| Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | 9 months after RT |
| Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | 1 month after RT |
| Percent of Participants With Delayed Wound Healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Lyons, MD | University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intraoperative Radiation Therapy | Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed. |
| FG001 | Intracavitary Balloon Brachytherapy | Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intraoperative Radiation Therapy | Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed. |
| BG001 | Intracavitary Balloon Brachytherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 1 month after radiation therapy (RT) |
|
up to 5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intraoperative Radiation Therapy | Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE V3 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Janice A. Lyons, MD | University Hospitals Cleveland Medical Center , Case Comprehensive Cancer Center | +1 216-844-2536 | Janice.Lyons@uhhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2009 | May 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D018270 | Carcinoma, Ductal, Breast |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| intraoperative radiation therapy | Radiation | Patients undergo radiotherapy |
|
| 12 months after RT |
| Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | 2 years after RT |
| Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | 3 years after RT |
| Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | 4 years after RT |
| Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | 5 years after RT |
| Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | 1 month after RT |
| Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | 3 month after RT |
| Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | 6 month after RT |
| Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | 12 month after RT |
| Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | 2 years after RT |
| Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | 3 years after RT |
| Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | 4 years after RT |
| Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | 5 years after RT |
| Cosmetic Outcome as Determined by an Established Scale | Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, with levels poor, fair, good, and excellent in increasingly positive outcomes. Excellent: Minimal or no difference in the size or shape of the treated breast Good: Slight difference in the size or shape of the treated breast Fair: Obvious difference in the shape and size of the treated breast Poor: Obvious difference in the shape and size of the treated breast | 1 month after RT & Q3mos for one year and at 5 years |
| Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| 1 month after RT |
| Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| 3 month after RT |
| Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| 6 month after RT |
| Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| 9 month after RT |
| Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| 12 month after RT |
| Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| 2 years after RT |
| Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| 3 years after RT |
| Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| 4 years after RT |
| Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| 5 years after RT |
| Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | 1 month after RT |
| Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | 3 month after RT |
| Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | 6 month after RT |
| Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | 9 month after RT |
| Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | 12 month after RT |
| Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | 2 years after RT |
| Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | 3 years after RT |
| Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | 4 years after RT |
| Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | 5 years after RT |
Wound healing rate, as measured by percent of participants with delayed wound healing
| 3 month after RT |
| Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | 6 month after RT |
| Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | 9 month after RT |
| Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | 12 month after RT |
| Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | 2 years after RT |
| Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | 3 years after RT |
| Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | 4 years after RT |
| Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | 5 years after RT |
| UHHS Chagrin Highlands Medical Center | Cleveland | Ohio | 44122 | United States |
| UHHS Westlake Medical Center | Cleveland | Ohio | 44145 | United States |
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
|
|
| Primary | Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 3 months after RT |
|
|
|
| Primary | Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 6 months after RT |
|
|
|
| Primary | Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 9 months after RT |
|
|
|
| Primary | Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 12 months after RT |
|
|
|
| Primary | Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 2 years after RT |
|
|
|
| Primary | Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 3 years after RT |
|
|
|
| Primary | Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 4 years after RT |
|
|
|
| Primary | Ipsilateral Breast Tumor Recurrence Rates | Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast. | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 5 years after RT |
|
|
|
| Primary | Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 1 month after RT |
|
|
|
| Primary | Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 3 month after RT |
|
|
|
| Primary | Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 6 month after RT |
|
|
|
| Primary | Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 12 month after RT |
|
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|
| Primary | Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 2 years after RT |
|
|
|
| Primary | Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 3 years after RT |
|
|
|
| Primary | Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 4 years after RT |
|
|
|
| Primary | Tumor Bed Recurrence Rates | Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 5 years after RT |
|
|
|
| Primary | Cosmetic Outcome as Determined by an Established Scale | Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, with levels poor, fair, good, and excellent in increasingly positive outcomes. Excellent: Minimal or no difference in the size or shape of the treated breast Good: Slight difference in the size or shape of the treated breast Fair: Obvious difference in the shape and size of the treated breast Poor: Obvious difference in the shape and size of the treated breast | Participants who had data collected for survey. Only participants in group 1 completed survey. | Posted | Number | percentage of participants | 1 month after RT & Q3mos for one year and at 5 years |
|
|
|
| Primary | Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| Evaluable participants enrolled in study | Posted | Number | percentage of participants | 1 month after RT |
|
|
|
| Primary | Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| Evaluable participants enrolled in study | Posted | Number | percentage of participants | 3 month after RT |
|
|
|
| Primary | Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| Evaluable participants enrolled in study | Posted | Number | percentage of participants | 6 month after RT |
|
|
|
| Primary | Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| Evaluable participants enrolled in study | Posted | Number | percentage of participants | 9 month after RT |
|
|
|
| Primary | Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| Evaluable participants enrolled in study | Posted | Number | percentage of participants | 12 month after RT |
|
|
|
| Primary | Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| Evaluable participants enrolled in study | Posted | Number | percentage of participants | 2 years after RT |
|
|
|
| Primary | Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| Evaluable participants enrolled in study | Posted | Number | percentage of participants | 3 years after RT |
|
|
|
| Primary | Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| Evaluable participants enrolled in study | Posted | Number | percentage of participants | 4 years after RT |
|
|
|
| Primary | Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey | Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
| Evaluable participants enrolled in study | Posted | Number | percentage of participants | 5 years after RT |
|
|
|
| Primary | Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 1 month after RT |
|
|
|
| Secondary | Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | Evaluable participants enrolled on study | Posted | Number | percentage of participants | 1 month after RT |
|
|
|
| Primary | Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 3 month after RT |
|
|
|
| Primary | Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 6 month after RT |
|
|
|
| Primary | Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 9 month after RT |
|
|
|
| Primary | Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 12 month after RT |
|
|
|
| Primary | Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 2 years after RT |
|
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|
| Primary | Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 3 years after RT |
|
|
|
| Primary | Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 4 years after RT |
|
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|
| Primary | Percent of Participants Experiencing Complications After Intervention | Overall complication rate, as measured by percent of participants experiencing complications after intervention | Evaluable participants enrolled in study | Posted | Number | percentage of participants | 5 years after RT |
|
|
|
| Secondary | Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | Evaluable participants enrolled on study | Posted | Number | percentage of participants | 3 month after RT |
|
|
|
| Secondary | Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | Evaluable participants enrolled on study | Posted | Number | percentage of participants | 6 month after RT |
|
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|
| Secondary | Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | Evaluable participants enrolled on study | Posted | Number | percentage of participants | 9 month after RT |
|
|
|
| Secondary | Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | Evaluable participants enrolled on study | Posted | Number | percentage of participants | 12 month after RT |
|
|
|
| Secondary | Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | Evaluable participants enrolled on study | Posted | Number | percentage of participants | 2 years after RT |
|
|
|
| Secondary | Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | Evaluable participants enrolled on study | Posted | Number | percentage of participants | 3 years after RT |
|
|
|
| Secondary | Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | Evaluable participants enrolled on study | Posted | Number | percentage of participants | 4 years after RT |
|
|
|
| Secondary | Percent of Participants With Delayed Wound Healing | Wound healing rate, as measured by percent of participants with delayed wound healing | Evaluable participants enrolled on study | Posted | Number | percentage of participants | 5 years after RT |
|
|
|
| 1 |
| 12 |
| 0 |
| 12 |
| 11 |
| 12 |
| EG001 | Intracavitary Balloon Brachytherapy | Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days. | 0 | 1 | 0 | 1 | 1 | 1 |
| Hemorrhage, pulmonary/upper respiratory - nose | Blood and lymphatic system disorders | CTCAE V3 | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE V3 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE V3 | Non-systematic Assessment |
|
| Insomnia | General disorders | CTCAE V3 | Non-systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE V3 | Non-systematic Assessment |
|
| Burn | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Breast indentation/dimpling | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Skin retraction | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Skin dimpling | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Induration/fibrosis (skin and subcutaneous tissue) | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Rash: dermatitis associated with radiation - Radiation | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Hot flashes/flushes | Endocrine disorders | CTCAE V3 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE V3 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE V3 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE V3 | Non-systematic Assessment |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE V3 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE V3 | Non-systematic Assessment |
|
| Breast Infection | Infections and infestations | CTCAE V3 | Non-systematic Assessment |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) | Infections and infestations | CTCAE V3 | Non-systematic Assessment |
|
| Edema: limb | Blood and lymphatic system disorders | CTCAE V3 | Non-systematic Assessment |
|
| Edema: trunk/genital | Blood and lymphatic system disorders | CTCAE V3 | Non-systematic Assessment |
|
| Lymphatics: seroma | Blood and lymphatic system disorders | CTCAE V3 | Non-systematic Assessment |
|
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE V3 | Non-systematic Assessment |
|
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Fibrosis-cosmesis | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Joint-function | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Superficial soft tissue breast fibrosis | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Seroma | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE V3 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE V3 | Non-systematic Assessment |
|
| Mood alteration - Depression | Nervous system disorders | CTCAE V3 | Non-systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE V3 | Non-systematic Assessment |
|
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Pain - Breast | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Pain - Dental/teeth/peridontal | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Pain - Head/headache | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Pain - Pelvis | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Pain - Skin | Musculoskeletal and connective tissue disorders | CTCAE V3 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE V3 | Non-systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE V3 | Non-systematic Assessment |
|
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTCAE V3 | Non-systematic Assessment |
|
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE V3 | Non-systematic Assessment |
|
| Breast nipple/areolar deformity | Reproductive system and breast disorders | CTCAE V3 | Non-systematic Assessment |
|
| Nipple Inversion | Reproductive system and breast disorders | CTCAE V3 | Non-systematic Assessment |
|
| Intra-operative injury - Skin | Surgical and medical procedures | CTCAE V3 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D044584 | Carcinoma, Ductal |
| Good |
|
| Fair |
|
| Poor |
|