Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Adjuvant Radiotherapy

• Registration Number: NCT00003404
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 1998-01
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2008-11-17
• Study Completion: 2008-11-17
• Results First Submitted: 2018-10-03
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-30
• Last Update Submitted: 2018-12-30
• Results First Posted: 2019-01-22
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjuvant Radiotherapy	Adjuvant Radiotherapy	Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.

Primary Outcome Measures

Name	Time	Method
Local Recurrence Rate	36 months after initial excision	Local recurrence rate of phyllodes tumors

Secondary Outcome Measures

Name	Time	Method
Survival Rate	Approximately 5 years	Survival will be tracked for 10 years after initial resection of first participant treated.

Trial Locations

Locations (1)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States