Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)
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|ClinicalTrials.gov Identifier: NCT02272400|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: IGRT for prone partial breast irradiation (PBI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||310 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)|
|Actual Study Start Date :||August 7, 2007|
|Estimated Primary Completion Date :||October 2024|
|Estimated Study Completion Date :||October 2024|
Experimental: IGRT of prone partial breast
IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy.
Other: IGRT for prone partial breast irradiation (PBI)
IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.
- Measure the outcome of applying IGRT to PBI [ Time Frame: 10 years ]
Apply IGRT to PBI as part of breast preservation in post-menopausal women with T1 breast cancers and acquire preliminary data on the role of this tool to assure correct targeting.
Measure local recurrence within the field of conformal radiation as well as local recurrence outside the field
- Feasibility of accelerated dose fractionation [ Time Frame: 1 - 10 years ]Assess the feasibility of an accelerated dose fractionation (600 cGy x 5) when given over five consecutive day by measuring the acute and late radiation toxicity
- Genetic pre-disposition of patient to post-treatment radiation fibrosis [ Time Frame: 1 - 10 years ]Prospectively determine if genetic factors can be identified which may predispose a patient to the development of post-treatment radiation fibrosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272400
|United States, New York|
|Laura and Isaac Perlmutter Cancer Center at NYU|
|New York, New York, United States, 10016|
|Principal Investigator:||Carmen Perez, M.D.||NYU Langone Medical Center|