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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01124 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| 0220100204 | Other Identifier | Rutgers IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rutgers Cancer Institute of New Jersey | OTHER |
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This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT after surgery may kill any remaining tumor cells
PRIMARY OBJECTIVES:
I. Freedom from local failure and freedom from regional failure.
SECONDARY OBJECTIVES:
I. Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy.
III. To correlate toxicity, cosmesis, and local control with molecular markers.
OUTLINE:
Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy | Experimental | Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External beam radiation therapy | Radiation | Hypofractionated accelerated radiation therapy over 11 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local, Regional, and/or Distant Failure | Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary. | Up to 5 years after dose of last treatment, an average of 62 months |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With Grade Three or Higher Toxicities | Adverse events will be monitored weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years. | weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Haffty, MD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States | ||
| Huntsman Cancer Hospital |
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Patients enrolled at the Rutgers Cancer Institute of New Jersey and at the Huntsman Cancer Institute at the University of Utah. After enrolling 69 patients with stage II-III breast cancer, 67 women were eligible for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy | Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Oct 18, 2018 |
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| Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications | Up to five years after dose of last treatment, an average of 62 months |
| Salt Lake City |
| Utah |
| 84103 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy | Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days |
| 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 | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 Local, Regional, and/or Distant Failure | Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary. | Posted | Count of Participants | Participants | Up to 5 years after dose of last treatment, an average of 62 months |
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| Secondary | Count of Participants With Grade Three or Higher Toxicities | Adverse events will be monitored weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years. | Posted | Number | participants | weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years. |
|
| ||||||||||||||||||||||||||||
| Secondary | Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications | Posted | Count of Participants | Participants | Up to five years after dose of last treatment, an average of 62 months |
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Up to five years after dose of last treatment, an average of 62 months
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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 Therapy | Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days | 6 | 67 | 1 | 67 | 67 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatology/Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Constitutional Symptoms | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Neurology | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Haffty | Cancer Institute of New Jersey Rutgers | 732-235-8675 | hafftybg@cinj.rutgers.edu |
| Mar 17, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2014 | Aug 12, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D058922 | Inflammatory Breast Neoplasms |
| D018270 | Carcinoma, Ductal, Breast |
| D018275 | Carcinoma, Lobular |
| D001943 | Breast Neoplasms |
| 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 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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