NCT00003404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 1998

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2008

Completed
10.2 years until next milestone

Results Posted

Study results publicly available

January 22, 2019

Completed
Last Updated

January 22, 2019

Status Verified

December 1, 2018

Enrollment Period

10.9 years

First QC Date

November 1, 1999

Results QC Date

October 3, 2018

Last Update Submit

December 30, 2018

Conditions

Breast Cancer

Keywords

recurrent breast cancerphyllodes tumor

Outcome Measures

Primary Outcomes (1)

  • Local Recurrence Rate

    Local recurrence rate of phyllodes tumors

    36 months after initial excision

Secondary Outcomes (1)

  • Survival Rate

    Approximately 5 years

Study Arms (1)

Adjuvant Radiotherapy

EXPERIMENTAL

Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.

Radiation: Adjuvant Radiotherapy

Interventions

Adjuvant RadiotherapyRADIATION

Adjuvant radiation therapy

Adjuvant Radiotherapy

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: 1. Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following: 1. Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia 2. Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia 2. Must have been excised with breast-conserving resection and no positive margins 3. Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision 4. No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast 5. Hormone receptor status: Not specified PATIENT CHARACTERISTICS: 1. Age: 18 and over 2. Sex: Female 3. Menopausal status: Not specified 4. Performance status: Not specified 5. Life expectancy: Not specified 6. Hematopoietic: Not specified 7. Hepatic: Not specified 8. Renal: Not specified 9. Other: 1. Not pregnant 2. Negative pregnancy test 3. Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: 1. Biologic therapy: Not specified 2. Chemotherapy: Not specified 3. Endocrine therapy: Not specified 4. Radiotherapy: No prior radiotherapy to the ipsilateral breast 5. Surgery: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Related Publications (1)

  • 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.

    PMID: 19424757RESULT

MeSH Terms

Conditions

Breast NeoplasmsPhyllodes Tumor

Interventions

Radiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsRadiotherapy

Results Point of Contact

Title
Richard J. Barth Jr., MD
Organization
Dartmouth Hitchcock Medical Center
Richard.J.Barth.Jr@hitchcock.org
(603) 650-9479

Study Officials

  • Richard J. Barth, MD

    Norris Cotton Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Section of General Surgery

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

January 1, 1998

Primary Completion

November 17, 2008

Study Completion

November 17, 2008

Last Updated

January 22, 2019

Results First Posted

January 22, 2019

Record last verified: 2018-12

Locations

US(1)