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NCT01215162 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT01215162: Completed Phase 2 study of Breast Cancer, sponsored by Mayo Clinic.
NCT01215162 is a Phase 2 study of Breast Cancer that has completed, run by Mayo Clinic. The registered enrollment target is 65 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01215162, a Phase 2 study of Breast Cancer, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually given after EBRT. Data from two centers as well as preliminary data from a randomized trial in Europe suggest that IOERT boost is well tolerated and efficacious. In our study, patients will undergo standard lumpectomy and sentinel lymph node sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy will be delivered in a single fraction to the tumor bed by a mobile electron machine in the operating room. EBRT to the whole breast will be administered once the surgical wound has healed adequately. The primary objective is to determine the feasibility and acute patient tolerance to IOERT and EBRT after lumpectomy. Secondary objectives include assessment of local control and distant control of disease, as well as evaluation of long-term side effects and cosmetic outcome of the treatment.
Primary Outcome
To determine the acute skin reaction, breast edema, pnemonitis, cardiac side effects during radiation using RTOG acute toxicity scale
Conditions Studied
Interventions
- RADIATION Intra-operative radiation to tumor bed
Study Locations (1)
Arizona
- Mayo Clinic - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2003-01 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01215162 record still lists
NCT01215162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Intra-operative radiation to tumor bed is the first listed.
NCT01215162 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01215162 about?
NCT01215162 is a clinical study titled "Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer". The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually gi...
What is the current status of trial NCT01215162?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2003-01. Estimated completion is 2013-01.
What conditions does trial NCT01215162 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01215162?
The interventions under investigation include: Intra-operative radiation to tumor bed (RADIATION).
Who is sponsoring clinical trial NCT01215162?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01215162 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01215162's enrollment target sits among peer trials
65 722nd of 1224 higher than 501 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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