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NCT01089374 · ClinicalTrials.gov registry record · NA
Phyllodes Tumor Partial Breast Radiation Study
A NA study, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT01089374 is a NA study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 11 participants.
The verdict
NCT01089374, a NA study, was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
In 2008 a research study conducted by Dr. Barth involving 46 women determined that whole breast radiation therapy performed after a lumpectomy of borderline and malignant phyllodes tumors decreases rate of recurrence. None of the 46 participants developed a local recurrence. Based on information we have learned from research studies, we recommend whole breast radiation therapy for women with malignant and borderline phyllodes tumors after they receive a lumpectomy. New methods for delivering breast radiotherapy are being developed that allow radiation to be delivered solely to the site of the surgical resection. This is called partial breast radiation. The main advantage of partial breast radiation is that it simplifies treatment for the patient. Radiation is delivered twice a day for 5 days, rather than 5 days per week for 6 weeks. The main concern is that partial breast radiation might miss other sites of breast cancer in the breast receiving the radiation. Evidence is accumulating from research studies that partial breast radiation therapy after surgical removal of the more common type of breast cancer, invasive ductal carcinoma, the breast results in rates of local recurrence that are comparable to those seen after whole breast radiation therapy. In contrast to patients with invasive ductal cancers of the breast, it is very rare for patients to have phyllodes tumors that appear in more than one area of the breast. Review of research data determined that cancer recurrences seen in patients with phyllodes tumors that had undergone lumpectomies were almost always at the original tumor site. Therefore, partial breast radiation is likely to be as effective as whole breast radiation therapy after resection of malignant phyllodes tumors. The purpose of the study is to determine what the chances are that a phyllodes tumor will recur in the breast when the breast is treated with partial breast radiation therapy after a lumpectomy.
Interventions
- RADIATION Partial breast radiation after lumpectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-01-12 |
| Est. Completion | 2021-06-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01089374
The ClinicalTrials.gov registry entry for NCT01089374 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Partial breast radiation after lumpectomy is the first listed.
NCT01089374 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01089374 about?
NCT01089374 is a clinical study titled "Phyllodes Tumor Partial Breast Radiation Study". In 2008 a research study conducted by Dr. Barth involving 46 women determined that whole breast radiation therapy performed after a lumpectomy of borderline and malignant phyllodes tumors decreases rate of recurrence. None of the 46 participants developed a local recurrence. Based on information we...
What is the current status of trial NCT01089374?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2010-01-12. Estimated completion is 2021-06-20.
What interventions are being tested in trial NCT01089374?
The interventions under investigation include: Partial breast radiation after lumpectomy (RADIATION).
Who is sponsoring clinical trial NCT01089374?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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