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NCT01468883 · ClinicalTrials.gov registry record · Phase 3
The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 256
- Enrollment target
NCT01468883: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT01468883 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 256 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468883, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 256 participants
- Enrollment target
Study Summary
Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation. Data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. This study will test this hypothesis in a prospective, randomized manner. After primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.
Interventions
- PROCEDURE M
- RADIATION X
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 1979-09-04 |
| Est. Completion | 2016-11-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01468883
The ClinicalTrials.gov registry entry for NCT01468883 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which M is the first listed.
NCT01468883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01468883 about?
NCT01468883 is a clinical study titled "The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation". Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation. Data from single institutions and from retrospe...
What is the current status of trial NCT01468883?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 1979-09-04. Estimated completion is 2016-11-17.
What interventions are being tested in trial NCT01468883?
The interventions under investigation include: M (PROCEDURE), X (RADIATION).
Who is sponsoring clinical trial NCT01468883?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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