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The Purpose of this study is to evaluate the feasibility of using image guidance and four-dimensional computed tomography to reduce the volume of non target breast tissue that is treated with accelerated partial breast irradiation via the external beam technique.
This is a pilot study enrolling about 30 patients to evaluate the feasibility of using 4D CT and daily image guidance in Accelerated Partial Breast Irradiation (APBI) to decrease set-up error and individualized planning target volumes to limit the non-target breast tissue dose. The two specific breasts constraints which shall be decreased are the V50 (percent volume of breast receiving 50% of the prescribed dose) and the V100 (percent volume of breast receiving 100% of the prescribed dose). The goal will be to decrease these to 45% and 23.5% respectively, which is down 33% from the NSABP B39 standard of 60% and 35%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4D Conformal Image-Guided Partial Breast RT | Experimental | This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4D Conformal Image-Guided Partial Breast RT | Radiation | External beam partial breast radiation to target a portion of the breast twice a day for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Reduction in Incidental Radiation | Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%. | 5 day |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis by Patient Report | This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score. | Within no more than 8 weeks of surgery, but prior to the start of radiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Evans, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Hospital Care Center, Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
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54 people were recruited to take part, however only 46 of those were treated and included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 4D Conformal Image-Guided Partial Breast RT | This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days. 4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4D Conformal Image-Guided Partial Breast RT | This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days. 4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Patients With Reduction in Incidental Radiation | Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%. | Posted | Count of Participants | Participants | 5 day |
|
|
Through treatment completion, and up to 3 years follow up.
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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 | 4D Conformal Image-Guided Partial Breast RT | This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days. 4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suzanne Evans, MD, MPH | Yale University | (203) 785-5175 | suzanne.evans@yale.edu |
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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 | Sep 5, 2014 | Sep 13, 2018 | Prot_SAP_000.pdf |
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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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|
| Cosmesis by Patient Report | This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score. | 1 year post treatment |
| Cosmesis by Patient Report | This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score. | 3 year post treatment |
| Cosmesis by Medical Doctor Report | Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae. | Within no more than 8 weeks of surgery, but prior to the start of radiation |
| Cosmesis by Medical Doctor Report | Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae. | 1 yr post treatment |
| Cosmesis by Medical Doctor Report | Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae. | 3 yr post treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Cosmesis by Patient Report | This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score. | Posted | Median | Full Range | units on a scale | Within no more than 8 weeks of surgery, but prior to the start of radiation |
|
|
|
| Secondary | Cosmesis by Patient Report | This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score. | Posted | Median | Full Range | units on a scale | 1 year post treatment |
|
|
|
| Secondary | Cosmesis by Patient Report | This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score. | Posted | Median | Full Range | units on a scale | 3 year post treatment |
|
|
|
| Secondary | Cosmesis by Medical Doctor Report | Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae. | Posted | Count of Participants | Participants | Within no more than 8 weeks of surgery, but prior to the start of radiation |
|
|
|
| Secondary | Cosmesis by Medical Doctor Report | Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae. | Posted | Count of Participants | Participants | 1 yr post treatment |
|
|
|
| Secondary | Cosmesis by Medical Doctor Report | Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae. | Posted | Count of Participants | Participants | 3 yr post treatment |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 45 |
| 46 |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Superficial soft tissue fibrosis | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fat atrophy | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin atrophy | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| poor |
|
| poor |
|
| poor |
|