| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer DCIS LCIS | Radiation: MRIdian Radiation Treatment Unit | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | This study will have a lead-in phase consisting of 10 patients, followed for 6-months from the date of completion of radiotherapy for the tenth patient. The second phase of accrual (20 patients) will commence only if three or fewer patients (3/10=30%) have CTCAE v 5.0 grade 3 or higher skin toxicity (radiation dermatitis) or Lövey et al. grade 3 or higher fat necrosis. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI) |
| Estimated Study Start Date : | June 2021 |
| Estimated Primary Completion Date : | July 1, 2022 |
| Estimated Study Completion Date : | July 1, 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 8.2 Gy Radiation Therapy
Accelerated partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm PTV margin. Treatment duration will be 5-6 days and treatments will be on alternative weekdays, with a minimum interval of 40 hours between subsequent fractions.
|
Radiation: MRIdian Radiation Treatment Unit
partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin
|
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For all participants
For participants with Invasive Carcinoma
Suitable:
Age: >=50 years
Cautionary:
Age: 40-49 years
Age: >=50 years IF participant has at least 1 of the pathologic factors below and does not have any "unsuitable" factors (below)
Pathologic Factors:
For participants with DCIS
Suitable Criteria, DCIS allowed if all of the following are met:
Cautionary Criteria:
Exclusion Criteria (unsuitable criteria) :
| United States, Wisconsin | |
| University of Wisconsin Carbone Cancer Center | |
| Madison, Wisconsin, United States, 53705 | |
| Principal Investigator: | Bethany Anderson, MD | University of Wisconsin, Madison |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 1, 2019 | ||||
| First Posted Date ICMJE | May 3, 2019 | ||||
| Last Update Posted Date | May 6, 2021 | ||||
| Estimated Study Start Date ICMJE | June 2021 | ||||
| Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Physician Reported Cosmesis: 1-year [ Time Frame: up to 1-year ] The Harvard Cosmesis Scale will be used to report cosmesis at 1 year post treatment. The physician will report how the breast looks relative to original appearance or untreated breast (excellent, good, fair, poor). The physician answers 9 questions on a scale of 0-2 where 0 is none, 1 is present but does not affect cosmesis, 2 is present and affects cosmesis. Scoring is objective with lower scores indicating improved conditions.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer | ||||
| Official Title ICMJE | A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI) | ||||
| Brief Summary | This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: This study will have a lead-in phase consisting of 10 patients, followed for 6-months from the date of completion of radiotherapy for the tenth patient. The second phase of accrual (20 patients) will commence only if three or fewer patients (3/10=30%) have CTCAE v 5.0 grade 3 or higher skin toxicity (radiation dermatitis) or Lövey et al. grade 3 or higher fat necrosis. Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Radiation: MRIdian Radiation Treatment Unit
partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin
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| Study Arms ICMJE | Experimental: 8.2 Gy Radiation Therapy
Accelerated partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm PTV margin. Treatment duration will be 5-6 days and treatments will be on alternative weekdays, with a minimum interval of 40 hours between subsequent fractions.
Intervention: Radiation: MRIdian Radiation Treatment Unit
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE |
30 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 1, 2026 | ||||
| Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: For all participants
For participants with Invasive Carcinoma
For participants with DCIS
Exclusion Criteria (unsuitable criteria) :
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| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03936478 | ||||
| Other Study ID Numbers ICMJE | UW18099 2019-0322 ( Other Identifier: Institutional Review Board ) SMPH\HUMAN ONCO\HUMAN ONCO ( Other Identifier: UW Madison ) A533300 ( Other Identifier: UW Madison ) NCI-2019-03111 ( Registry Identifier: NCI Trial ID ) Protocol Version 3/10/2020 ( Other Identifier: UW Madison ) |
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| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Wisconsin, Madison | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Wisconsin, Madison | ||||
| Verification Date | February 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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