Dose Escalation Study of Single Fraction Early Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04040569|
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : May 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Radiomics on MRI||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients in each dose cohort will be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 30 Gy. Subsequent cohorts of patients will receive an additional 4 Gy per treatment.|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose Escalation Study of Single Fraction Pre-operative Partial Breast (S-PBI) for Early Stage Breast Cancer|
|Actual Study Start Date :||December 25, 2019|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||August 2025|
Experimental: Single-fraction stereotactic partial breast radiotherapy
The primary objective is to escalate the dose of 1 fraction stereotactic partial breast radiotherapy utilizing the MR Linac,Gammapod or Cyberknife system to an ablative dose in the pre-operative setting to the primary tumor without exceeding the maximum tolerated dose in patients with early stage breast cancer.
Radiation: Radiomics on MRI
Through extracting and analyzing a large number of features from medical imaging, radiomics has shown promising results in treatment outcome prediction for many diseases including breast cancer (45-50). UTSW physics group has developed several new radiomic approaches and radiomic features, such as a multi-objective radiomics model(51) and a new radiomic "Shell" feature(52). As an exploratory end point for this trial, the investigators will explore the application radiomics using pre-treatment MRI, treatment parameters and clinical characteristics as input to predict pathological response of radiation therapy (XRT) based on pathology report of surgical tissues and local recurrence.
- Reach the maximum tolerated dose (MTD) or a dose of 38 Gy total [ Time Frame: 5 years ]Done by escalating the dose of SBRT toward the tumorcidal dose of 38 Gy in fraction. Doses will be escalated an additional 3.5-4 Gy per treatment. The phase I portion of the study will be completed when either of the following events occur: 1) the MTD for a cohort is reached or 2) when delivery of a pre-determined highest dose of radiation (38 Gy) that has been deemed likely to be efficacious for treatment of early stage breast cancer is attained.Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.
- Cosmesis outcome [ Time Frame: 5 years ]Photographs of both breasts will be taken and cosmesis form will be graded by the patient, and the radiation oncologist, at twelve months from the start of therapy and at yearly intervals thereafter for up to 5 years after treatment. In addition, an independent panel established at University of Texas Southwestern Medical Center will evaluate cosmesis at the end of study based on photography.
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): NCT04040569
|Contact: Sarah Hardee, MSemail@example.com|
|Contact: Kajal Desaifirstname.lastname@example.org|
|United States, Texas|
|University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Asal Rahimi, MD||UT Southwestern Medical Center|