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NCT01266642 · ClinicalTrials.gov registry record · Phase 2
Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
A Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 301
- Enrollment target
- 7
- Study locations
NCT01266642: Active Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
NCT01266642 is a Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 301 participants, below the 478-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (37% lower). The trial reports 7 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01266642, a Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 301 participants
- Enrollment target
- 7
- Study locations
Study Summary
This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor cells. Giving higher doses of RT over a shorter period of time may kill more tumor cells and have fewer side effects. It is not yet known if hypofractionated RT is more effective than standard RT in treating breast cancer.
Primary Outcome
BCTOS cosmesis score range from 1 to 4, and scores of 2.5 or more indicate adverse cosmetic outcomes.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- RADIATION External Beam Radiation Therapy
- OTHER Laboratory Biomarker Analysis
- RADIATION Hypofractionated Radiation Therapy
Study Locations (7)
Texas
- MD Anderson in The Woodlands - Conroe
- M D Anderson Cancer Center - Houston
- MD Anderson West Houston - Houston
- MD Anderson League City - League City
- MD Anderson in Sugar Land - Sugar Land
Arizona
- Banner MD Anderson Cancer Center - Gilbert
Florida
- UF Cancer Center at Orlando Health - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2011-02-08 |
| Est. Completion | 2040-11-30 |
| Phase | Phase 2 |
What the registry record for NCT01266642 still lists
NCT01266642 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 478-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (37% lower).
The record links to 8 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01266642 lists 7 locations in 3 states (Texas, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT01266642 about?
NCT01266642 is a clinical study titled "Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer". This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor cells. Giving higher do...
What is the current status of trial NCT01266642?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 301 participants. The study started on 2011-02-08. Estimated completion is 2040-11-30.
What conditions does trial NCT01266642 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Ductal Breast Carcinoma in Situ, Stage IB Breast Cancer AJCC v7.
What interventions are being tested in trial NCT01266642?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), External Beam Radiation Therapy (RADIATION), Laboratory Biomarker Analysis (OTHER), Hypofractionated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01266642?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01266642 being conducted?
This trial has 7 study locations across Arizona, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Breast Carcinoma
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 NCT01266642's enrollment target sits among peer trials
301 14th of 45 higher than 32 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma 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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