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| Name | Class |
|---|---|
| The Miriam Hospital | OTHER |
| Rhode Island Hospital | OTHER |
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The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation | Experimental | AccuBoost APBI- 34.0 Gy in 10fx |
|
| Extended Follow up | Experimental | This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated partial breast irradiation | Radiation | Accuboost APBI 34.0 Gy in 10 fractions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Early and Intermediate Toxicity | Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic Outcome | Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaroslaw Hepel, MD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Cancer Care and Research- Watson Clinic | Lakeland | Florida | 33805 | United States | ||
| Brown University Oncology Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32721422 | Derived | Hepel JT, Leonard KL, Sha S, Graves TA, Wiggins DL, Mastras D, Pittier A; Brown University Oncology Research Group; Wazer DE. Phase 2 Trial of Accelerated Partial Breast Irradiation (APBI) Using Noninvasive Image Guided Breast Brachytherapy (NIBB). Int J Radiat Oncol Biol Phys. 2020 Dec 1;108(5):1143-1149. doi: 10.1016/j.ijrobp.2020.07.2312. Epub 2020 Jul 25. | |
| 24997723 |
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40 patients must COMPLETE treatment. 41 were registered because 1 was removed secondary to Physician decision to not continue treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation | AccuBoost APBI- 34.0 Gy in 10fx Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation | AccuBoost APBI- 34.0 Gy in 10fx Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Early and Intermediate Toxicity | Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table. | Posted | Number | participants | 2 years |
|
Data was collected from signing of ICF until 2 years post treatment.
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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 | Radiation | AccuBoost APBI- 34.0 Gy in 10fx Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaroslaw Hepel | BrUOG-Brown University Oncology Research Group | 4018633000 | kristen_mitchell@brown.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Extended Follow up |
| Other |
This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed. |
|
| Providence |
| Rhode Island |
| 02903 |
| United States |
| Lifespan Hospitals | Providence | Rhode Island | 02903 | United States |
| Tacoma Radiation | Tacoma | Washington | 98405-4250 | United States |
| Hepel JT, Hiatt JR, Sha S, Leonard KL, Graves TA, Wiggins DL, Mastras D, Pittier A; Brown University Oncology Research Group; Wazer DE. The rationale, technique, and feasibility of partial breast irradiation using noninvasive image-guided breast brachytherapy. Brachytherapy. 2014 Sep-Oct;13(5):493-501. doi: 10.1016/j.brachy.2014.05.014. Epub 2014 Jul 3. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Cosmetic Outcome | Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table. | Posted | Number | participants | 2 years |
|
|
|
| 1 |
| 41 |
| 40 |
| 41 |
| Creatinine | Investigations | Systematic Assessment |
|
| Hypokalemia | Investigations | Systematic Assessment |
|
| Bicarbonate | Investigations | Systematic Assessment |
|
| SGOT | Investigations | Systematic Assessment |
|
| Alkaline Phosphatase value | Investigations | Systematic Assessment |
|
| Hyperbilirubineamia | Investigations | Systematic Assessment |
|
| Hypoalbuminemia | Investigations | Systematic Assessment |
|
| Leukocytes | Investigations | Systematic Assessment |
|
| Hemoglobin | Investigations | Systematic Assessment |
|
| Neutrophils | Investigations | Systematic Assessment |
|
| INR | Investigations | Systematic Assessment |
|
| PTT | Investigations | Systematic Assessment |
|
| Fibrinogen | Investigations | Systematic Assessment |
|
| acute skin rxn | Investigations | Systematic Assessment |
|
| skin induration/fibrosis | Investigations | Systematic Assessment |
|
| hyperpigmentation | Investigations | Systematic Assessment |
|
| fatigue | Investigations | Systematic Assessment |
|
| breast volume | Investigations | Systematic Assessment |
|
| seroma | Investigations | Systematic Assessment |
|
| fat necrosis | Investigations | Systematic Assessment |
|
| Itching | Investigations | Systematic Assessment |
|
| Fibrosis Cosmesis | Investigations | Systematic Assessment |
|
| Talangiectasis | Investigations | Systematic Assessment |
|
| breast pain | Investigations | Systematic Assessment |
|
| Nausea | Investigations | Systematic Assessment |
|
| Diarrhea | Investigations | Systematic Assessment |
|
| erythema | Investigations | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |