Breast CancerNCT00003404
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
A study testing Adjuvant Radiotherapy in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adjuvant Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to 17 Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
About this study
Official title: A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Adjuvant Radiotherapy
- Keywords
- recurrent breast cancer, phyllodes tumor
- Medical subject headings
- Breast Neoplasms, Phyllodes Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant RadiotherapyRadiation
Adjuvant radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Radiotherapy | Experimental | Adjuvant radiation was started within 12 weeks of local excision or breast re-excision. Receives: Radiation: Adjuvant Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Recurrence Rate
Local recurrence rate of phyllodes tumors
Measured: 36 months after initial excision
Secondary outcomes (1)
Survival Rate
Survival will be tracked for 10 years after initial resection of first participant treated.
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 1998
- Primary completion17 Nov 2008
- Study completion17 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center
- Investigators
- Richard J. Barth, MD, Study chair, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003404
- Sponsor's protocol ID
- D9801 CDR0000066410
- Other IDs
- P30CA023108, DMS-9801, DMS-12752, NCI-V98-1442
- Status last verified
- Dec 2018
- First submitted
- 1 Nov 1999
- Last updated
- 22 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 19424757
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
- ClinicalTrials.gov ID
- NCT00003404
- Acronym / sponsor ID
- D9801 CDR0000066410
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, phyllodes tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 1998 (actual)
- Primary completion
- 17 Nov 2008 (actual)
- Study completion
- 17 Nov 2008 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 22 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Radiotherapy | Experimental | Radiation: Adjuvant RadiotherapyAdjuvant radiation was started within 12 weeks of local excision or breast re-excision. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant RadiotherapyAdjuvant radiation therapy | Radiation | Adjuvant Radiotherapy |
Primary outcome
Local Recurrence Rate
Time frame: 36 months after initial excision
Local recurrence rate of phyllodes tumors
1 secondary outcome
Survival Rate
Time frame: Approximately 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19424757Barth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J. Barth, MD study chair
Norris Cotton Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjuvant Radiotherapy in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Recurrence Rate (time frame: 36 months after initial excision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.