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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA023108 | U.S. NIH Grant/Contract | View source | |
| DMS-9801 | |||
| DMS-12752 | |||
| NCI-V98-1442 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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PURPOSE: This phase II trial studied how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.
OBJECTIVES:
METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Radiotherapy | Experimental | Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant Radiotherapy | Radiation | Adjuvant radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Recurrence Rate | Local recurrence rate of phyllodes tumors | 36 months after initial excision |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | Survival will be tracked for 10 years after initial resection of first participant treated. | Approximately 5 years |
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DISEASE CHARACTERISTICS:
Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:
Must have been excised with breast-conserving resection and no positive margins
Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision
No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
Hormone receptor status: Not specified
PATIENT CHARACTERISTICS:
Age: 18 and over
Sex: Female
Menopausal status: Not specified
Performance status: Not specified
Life expectancy: Not specified
Hematopoietic: Not specified
Hepatic: Not specified
Renal: Not specified
Other:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Richard J. Barth, MD | Norris Cotton Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19424757 | Result | Barth RJ Jr, Wells WA, Mitchell SE, Cole BF. A prospective, multi-institutional study of adjuvant radiotherapy after resection of malignant phyllodes tumors. Ann Surg Oncol. 2009 Aug;16(8):2288-94. doi: 10.1245/s10434-009-0489-2. Epub 2009 May 8. |
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Patients were enrolled from a total of 30 different institutions. Half of the patients were treated at community-based treatment centers, and half were treated at academic medical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adjuvant Radiotherapy | Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adjuvant Radiotherapy | Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Local Recurrence Rate | Local recurrence rate of phyllodes tumors | Posted | Count of Participants | Participants | 36 months after initial excision |
|
|
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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 | Adjuvant Radiotherapy | Adjuvant radiation after local excision or breast re-excision. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard J. Barth Jr., MD | Dartmouth Hitchcock Medical Center | (603) 650-9479 | Richard.J.Barth.Jr@hitchcock.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003557 | Phyllodes Tumor |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D018714 | Radiotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D011878 | Radiotherapy |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Survival Rate | Survival will be tracked for 10 years after initial resection of first participant treated. | All patients received adjuvant radiotherapy as specified in the protocol. No patients were lost to follow-up. Duration of follow-up ranged from 12 to 129 months, with a median follow-up of 56 months and a mean follow-up of 60 months. Ninety percent of the patients were followed for at least 2 years. | Posted | Count of Participants | Participants | Approximately 5 years |
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| 2 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |