Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
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|ClinicalTrials.gov Identifier: NCT00003404|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 30, 2015
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.
PURPOSE: This phase II trial is studying how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- 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.
OUTLINE: Within 12 weeks after prior local excision or breast reexcision, patients undergo adjuvant radiotherapy 5 days a week for a total of 28 treatments.
Patients are followed every 6 months for 10 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within approximately 6-7 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 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|
|Study Start Date :||January 1998|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|Experimental: Radiation||Procedure: adjuvant therapy Radiation: radiation therapy|
- Local recurrence rate [ Time Frame: 36 months ]
- Survival rate [ Time Frame: 10 years ]
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|