Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
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|ClinicalTrials.gov Identifier: NCT00003404|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 21, 2019
Last Update Posted : January 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Adjuvant Radiotherapy||Not Applicable|
- Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.
- Determine the survival rate in patients treated with this regimen.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors|
|Actual Study Start Date :||January 1998|
|Actual Primary Completion Date :||November 17, 2008|
|Actual Study Completion Date :||November 17, 2008|
Experimental: Adjuvant Radiotherapy
Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
Radiation: Adjuvant Radiotherapy
Adjuvant radiation therapy
- Local Recurrence Rate [ Time Frame: 36 months after initial excision ]Local recurrence rate of phyllodes tumors
- Survival Rate [ Time Frame: Approximately 5 years ]Survival will be tracked for 10 years after initial resection of first participant treated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003404
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Study Chair:||Richard J. Barth, MD||Norris Cotton Cancer Center|