Completed

A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors

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What is being tested

Adjuvant Radiotherapy

Radiation
Who is being recruted

Breast Diseases+7

+ Neoplasms

+ Neoplasms by Histologic Type

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 1998
See protocol details

Summary

Principal SponsorDartmouth-Hitchcock Medical Center
Last updated: January 22, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003404
Principal SponsorDartmouth-Hitchcock Medical Center
Last updated: January 22, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteSarcomaSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective and Soft TissueBreast NeoplasmsPhyllodes Tumor

Criteria

DISEASE CHARACTERISTICS: Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following: Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia 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: Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the ipsilateral breast Surgery: See Disease Characteristics

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, United StatesOpen Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center in Google Maps
CompletedOne Study Center