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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000666991 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily, 5 days a week, for 3 weeks.
Some patients undergo blood sample collection at baseline and within 3 weeks after completion of radiotherapy for circulating tumor cells analysis.
Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following radiotherapy.
After completion of study therapy, patients are followed up periodically for 4-5 years and then every year thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial Breast Re-Irradiation | Experimental | Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-Conformal External Beam | Radiation | Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events | Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible & started protocol treatment) would provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate was at least 13%; 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have treatment-related AEs, then the treatment-related AE rate was considered unacceptable. | From the end of radiation to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| In-breast Recurrence | The definition of treatment failure is histologic evidence of recurrent carcinoma, either invasive or non-invasive (except LCIS) in the ipsilateral breast. Clinical evidence of carcinoma by physical examination and/or mammograms and/or MRI will not be construed as evidence of treatment failure without biopsy proof but will be considered as suspicious for recurrence. Ipsilateral breast recurrences will be considered local (infield) if they occur within the prescription isodose volume; they will be considered peripheral if they occur between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume. Ipsilateral recurrences will be considered non-contiguous or extra field if they are beyond the peripheral volume described above. |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed locally recurrent breast carcinoma consistent with the following cell types:
Invasive ductal breast carcinoma
Medullary ductal breast carcinoma
Tubular ductal breast carcinoma
Mucinous ductal breast carcinoma
Lobular breast carcinoma
Ductal carcinoma in situ (DCIS)
Target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole-breast reference volume must be < 30% based on a post-operative, pre-treatment CT scan
Tumor size ≤ 3 cm in greatest dimension on pathologic specimen
Negative histologic margins of resection and no tumor on ink following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins)
Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension
If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel lymph node (SLN) evaluation is not required, but if performed:
Patients with a negative sentinal lymph node (SLN) biopsy are eligible for enrollment
Patients with a positive SLN biopsy require an axillary lymph node (ALN) dissection (ALND is not required if the SLN is not identified)
Patient is eligible if 0-3 positive ALNs without extracapsular extension is documented
If the in-breast recurrence is invasive disease and:
No prior ALN dissection or SLN dissection only:
• Prior ALN dissection: negative clinical exam: patient is eligible for enrollment
Prior ALN dissection: positive clinical exam: biopsy required
Ipsilateral breast mammogram and MRI within 120 days prior to study entry
Contralateral breast mammogram within 12 months of study entry
For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan
No multicentric ipsilateral breast recurrence or regional recurrence (other than axilla)
Patients must have a breast technically amenable to partial-breast irradiation
No metastatic disease documented by physical exam or radiographic evaluation (for patients with invasive disease)
No skin involvement
No prior contralateral mastectomy
Estrogen and progesterone status must be known
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas W. Arthur, MD | Massey Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Center for Cancer Care - Peoria | Peoria | Arizona | 85381 | United States | ||
| Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Partial Breast Re-Irradiation | Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. |
| Freedom From Mastectomy | Failure is mastectomy of the treated breast. Mastectomy rate at 3 years is reported, using the cumulative incidence with death as competing risk. Mastectomy-free survival is reported in outcome measure 10. | From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. |
| Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs) | CTCs in peripheral blood were assessed using the CellSearch (trademark) system. A stringent algorithm was used to classify cell images as a CTC. A CTC must express EpCAM [epithelial cell adhesion molecule] and not leukocyte lineage-specific antigens, exhibit cytoplasmic expression of cytokeratin, and contain a nucleus that binds DAPI [4',6-doamidino-2-phenylindole]. A cell image is not a CTC if any of the previous criterion are missing. A subject is categorized as "Detectable" if the patient had a CTC and "Undetectable" if the subject had no CTCs. If neither category could be determined, then the subject was categorized as "Unevaluable." | Prior to the start of radiation and 3 weeks after last radiation treatment. |
| Treatment-related Adverse Events (AEs) Any Time | AEs were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The overall highest grade for each patient was computed from all reported adverse events definitely, probably, or possibly related to protocol treatment. | From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis. |
| Distant Metastasis-free Survival | Failures are appearance of ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrences; distant metastases confirmed radiographically and/or pathologically; or death due to any cause. Note that a distant metastases was only considered a treatment failure if accompanied by an in-breast recurrence. | From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years. |
| Mastectomy-free Survival | Failure is mastectomy of the treated breast or death due to any cause. Mastectomy-free survival rate at three years was estimated using the Kaplan-Meier method. | From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. |
| Overall Survival | Failure is death due to any cause. Three-year overall survival rate was estimated using the Kaplan-Meier method. | From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. |
| Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation | AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from reported adverse events definitely, probably, or possibly related to protocol treatment occurring after one year from completion of re-irradiation. | After 1 year from the end of radiation. |
| Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) | The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 12 months minus the value at baseline. A positive change reflects a decline at 12 months and a negative change reflects an improvement at 12 months. | Baseline and 12 months from the start of radiation treatment. |
| Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) | The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 36 months minus the value at baseline. A positive change reflects a decline at 36 months and a negative change reflects an improvement at 36 months. | Baseline and 36 months from the start of radiation treatment. |
| Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale | Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale: Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast. Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast. Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast. Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue. | Baseline,12, and 36 Months from the start of radiation treatment. |
| 12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale | Patient-Reported BCTOS is comprised of 3 subscales (functional status, cosmetic status, breast specific pain). Responses for each item form a 4-point Likert scale evaluating the differences between the treated and untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). Higher scores reflect poorer outcomes. Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale: Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast. Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast. Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast. Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue. | 12 Months from the start of radiation treatment. |
| Burbank |
| California |
| 91505 |
| United States |
| University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado | 80045 | United States |
| JFK Medical Center | Atlantis | Florida | 33462 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Cancer Institute at St. John's Hospital | Springfield | Illinois | 62702 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| St. Agnes Hospital Cancer Center | Baltimore | Maryland | 21229 | United States |
| Central Maryland Oncology Center | Columbia | Maryland | 21044 | United States |
| Tate Cancer Center at Baltimore Washington Medical Center | Glen Burnie | Maryland | 21061 | United States |
| Cape Cod Hospital | Hyannis | Massachusetts | 02601 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| McLaren Cancer Institute | Flint | Michigan | 48532 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| Barnes-Jewish West County Hospital | St Louis | Missouri | 63141 | United States |
| Memorial Sloan-Kettering Cancer Center - Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| St. Barnabas Medical Center Cancer Center | Livingston | New Jersey | 07039 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740-6395 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | 08053 | United States |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Sands Cancer Center | Canandaigua | New York | 14424 | United States |
| Memorial Sloan-Kettering Cancer Center | Commack | New York | 11725 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | 10032 | United States |
| Highland Hospital of Rochester | Rochester | New York | 14620 | United States |
| University Radiation Oncology at Parkridge Hospital | Rochester | New York | 14626 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Memorial Sloan-Kettering Cancer Center - Rockville Centre | Rockville Centre | New York | 11570 | United States |
| Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York | 10591 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Barberton Citizens Hospital | Barberton | Ohio | 44203 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Community Memorial Hospital Cancer Care Center | Menomonee Falls | Wisconsin | 53051 | United States |
| Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin | 53097 | United States |
| Columbia-Saint Mary's Cancer Care Center | Milwaukee | Wisconsin | 53211 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Cross Cancer Institute at University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| Has Baseline PT QOL Data | Eligible patients who consented to QOL study & have patient-reported baseline data |
|
| Has Baseline MD QOL Data | Eligible patients who consented to QOL study & have physician-assessed baseline data |
|
| Has Baseline/12-month PT QOL Data | Eligible patients who consented to QOL study & have patient-reported baseline/12-month data |
|
| Has Baseline/12-Month MD QOL Data | Eligible patients who consented to QOL study & have physician-assessed baseline/12-month data |
|
| Has Baseline/36-month PT QOL Data | Eligible patients who consented to QOL study & have patient-reported baseline/36-month data |
|
| Has Baseline/36-Month MD QOL Data | Eligible patients who consented to QOL study & have physician-assessed baseline/36-month data |
|
| All Eligible Patients |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Partial Breast Re-Irradiation | Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events | Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible & started protocol treatment) would provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate was at least 13%; 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have treatment-related AEs, then the treatment-related AE rate was considered unacceptable. | The first 55 eligible patients who completed treatment and achieved 1 year of follow-up. | Posted | Number | participants | From the end of radiation to 1 year. |
|
|
| ||||||||||||||||||||||||||
| Secondary | In-breast Recurrence | The definition of treatment failure is histologic evidence of recurrent carcinoma, either invasive or non-invasive (except LCIS) in the ipsilateral breast. Clinical evidence of carcinoma by physical examination and/or mammograms and/or MRI will not be construed as evidence of treatment failure without biopsy proof but will be considered as suspicious for recurrence. Ipsilateral breast recurrences will be considered local (infield) if they occur within the prescription isodose volume; they will be considered peripheral if they occur between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume. Ipsilateral recurrences will be considered non-contiguous or extra field if they are beyond the peripheral volume described above. | All eligible patients. | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. |
|
| ||||||||||||||||||||||||||
| Secondary | Freedom From Mastectomy | Failure is mastectomy of the treated breast. Mastectomy rate at 3 years is reported, using the cumulative incidence with death as competing risk. Mastectomy-free survival is reported in outcome measure 10. | All eligible patients. | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs) | CTCs in peripheral blood were assessed using the CellSearch (trademark) system. A stringent algorithm was used to classify cell images as a CTC. A CTC must express EpCAM [epithelial cell adhesion molecule] and not leukocyte lineage-specific antigens, exhibit cytoplasmic expression of cytokeratin, and contain a nucleus that binds DAPI [4',6-doamidino-2-phenylindole]. A cell image is not a CTC if any of the previous criterion are missing. A subject is categorized as "Detectable" if the patient had a CTC and "Undetectable" if the subject had no CTCs. If neither category could be determined, then the subject was categorized as "Unevaluable." | Eligible patients who consented to participate in the CTC portion of the trial | Posted | Count of Participants | Participants | Prior to the start of radiation and 3 weeks after last radiation treatment. |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment-related Adverse Events (AEs) Any Time | AEs were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The overall highest grade for each patient was computed from all reported adverse events definitely, probably, or possibly related to protocol treatment. | All eligible patients | Posted | Number | percentage of participants | From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis. |
|
| |||||||||||||||||||||||||||
| Secondary | Distant Metastasis-free Survival | Failures are appearance of ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrences; distant metastases confirmed radiographically and/or pathologically; or death due to any cause. Note that a distant metastases was only considered a treatment failure if accompanied by an in-breast recurrence. | All eligible patients. | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years. |
|
| ||||||||||||||||||||||||||
| Secondary | Mastectomy-free Survival | Failure is mastectomy of the treated breast or death due to any cause. Mastectomy-free survival rate at three years was estimated using the Kaplan-Meier method. | All eligible patients. | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Failure is death due to any cause. Three-year overall survival rate was estimated using the Kaplan-Meier method. | All eligible patients. | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. |
|
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| Secondary | Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation | AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from reported adverse events definitely, probably, or possibly related to protocol treatment occurring after one year from completion of re-irradiation. | All eligible patients | Posted | Number | percentage of participants | After 1 year from the end of radiation. |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) | The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 12 months minus the value at baseline. A positive change reflects a decline at 12 months and a negative change reflects an improvement at 12 months. | Eligible patients who consented to participate in the quality of life study and have baseline and 12-month BCTOS data | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months from the start of radiation treatment. |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) | The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 36 months minus the value at baseline. A positive change reflects a decline at 36 months and a negative change reflects an improvement at 36 months. | Eligible patients who consented to participate in the quality of life study and have baseline and 36-month BCTOS data | Posted | Mean | Standard Deviation | units on a scale | Baseline and 36 months from the start of radiation treatment. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale | Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale: Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast. Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast. Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast. Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue. | Eligible patients who consented to participate in the quality of life study and have baseline data | Posted | Count of Participants | Participants | Baseline,12, and 36 Months from the start of radiation treatment. |
|
| |||||||||||||||||||||||||||
| Secondary | 12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale | Patient-Reported BCTOS is comprised of 3 subscales (functional status, cosmetic status, breast specific pain). Responses for each item form a 4-point Likert scale evaluating the differences between the treated and untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). Higher scores reflect poorer outcomes. Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale: Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast. Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast. Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast. Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue. | Eligible patients who consented to participate in the quality of life study and have baseline and 12-month BCTOS data | Posted | Mean | Standard Deviation | units on a scale | 12 Months from the start of radiation treatment. |
|
Not provided
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Partial Breast Re-Irradiation | Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total | 3 | 58 | 52 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Breast atrophy | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld, M.S. | NRG Oncology | seiferheldw@nrgoncology.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018270 | Carcinoma, Ductal, Breast |
| D018275 | Carcinoma, Lobular |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D002278 | Carcinoma in Situ |
Not provided
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| OG002 | Breast-Specific Pain Score | Patient-Reported: 12-Month Breast-Specific Pain Score |
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