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NCT01570998 · ClinicalTrials.gov registry record · NA
Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
A NA study of Stage IIA Breast Cancer and Stage IA Breast Cancer, sponsored by University of California, San Francisco.
- Active
- Registry status
- NA
- Development phase
- 1,259
- Enrollment target
- 20
- Study locations
NCT01570998: Active NA study of Stage IIA Breast Cancer and Stage IA Breast Cancer, sponsored by University of California, San Francisco.
NCT01570998 is a NA study of Stage IIA Breast Cancer and Stage IA Breast Cancer that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 1,259 participants, above the 184-participant average among 17 other Stage IIA Breast Cancer trials with a reported enrollment target (584% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01570998, a NA study of Stage IIA Breast Cancer and Stage IA Breast Cancer, is active but no longer recruiting, sponsored by University of California, San Francisco.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,259 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.
Primary Outcome
Local tumor control is defined as no recurrent tumor in the ipsilateral breast. Patients will be regularly monitored as per the individual center's policy provided this meets the minimum trial criteria for follow-up with physical examination at least every 6 months for 3 years and yearly at 4 and 5 years post-treatment. Confirmation of recurrence will follow clinical examination and cytology or biopsy. The two patient cohorts will not be separated for the analysis regarding local control.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Intraoperative Radiation Therapy
Study Locations (20)
California
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- University of California, Irvine - Irvine
- Dignity Health - California Hospital Medical Center - Los Angeles
- University of California, San Francisco - San Francisco
- John Muir Medical Center-Walnut Creek - Walnut Creek
New York
- Community Hospital at Dobbs Ferry - Dobbs Ferry
- Cornell University - Ithaca
- Columbia University/Herbert Irving Cancer Center - New York
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
- MedStar Washington Hospital Center - Washington D.C.
Florida
- Cleveland Clinic - Fort Lauderdale
- Holy Cross Hospital - Fort Lauderdale
Illinois
- Northwestern University - Chicago
- Loyola University Medical Center - Maywood
Connecticut
- Greenwich Hospital - Greenwich
Georgia
- Memorial Health University Medical Center - Savannah
Indiana
- Community Cancer Center South - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,259 participants |
| Start Date | 2012-05-18 |
| Est. Completion | 2028-12-31 |
| Phase | NA |
What the registry record for NCT01570998 still lists
NCT01570998 is an interventional study that assigns participants to a tested intervention. Its 1,259 participants enrollment target places it among the larger protocols in the corpus, above the 184-participant average among 17 other Stage IIA Breast Cancer trials with a reported enrollment target (584% higher).
The record links to 2 conditions, with Stage IIA Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01570998 names 20 study sites across 11 states, led by California, New York, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01570998 about?
NCT01570998 is a clinical study titled "Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery". This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room ...
What is the current status of trial NCT01570998?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,259 participants. The study started on 2012-05-18. Estimated completion is 2028-12-31.
What conditions does trial NCT01570998 study?
This clinical trial studies the following conditions: Stage IIA Breast Cancer, Stage IA Breast Cancer.
What interventions are being tested in trial NCT01570998?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Intraoperative Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01570998?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01570998 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IIA Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01570998's enrollment target sits among peer trials
1,259 1st of 17 higher than 17 of 17 other Stage IIA Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IIA Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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