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Trial Title:
Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation
NCT ID:
NCT05731791
Condition:
Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Phase 3 two-armed randomized clinical trial for localized favorable breast cancer
patients, randomizing to CT-based radiation treatment vs. MRI-based radiation treatment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiation Therapy to partial breast
Description:
Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast
radiotherapy with CT-based breast radiation treatment (Arm 1) and patients randomized to
ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based
breast radiation treatment (Arm 2).
Arm group label:
ARM 1 - CT-based breast radiation treatment
Arm group label:
ARM 2 - MRI-based breast radiation treatment
Summary:
The Investigators are investigating the potential role of MRI-guided Radiation Therapy
for patients receiving breast radiotherapy in the prone position with a MRI-Linac
radiotherapy system, the Precision Prone Irradiation (PPI) technique.
Hypothesis: The investigators would like to hypothesize that breast radiation therapy
using MRI-guided system including the MRI-Linac (Arm 2) is comparable to the current
standard of treatment using conventional CT-based system (Arm 1), in terms of local
control of the disease at 2 year time point.
Detailed description:
Breast conserving surgery and adjuvant whole breast radiotherapy is a standard treatment
option for most patients with early-stage invasive breast cancer. Recent technological
advances in radiotherapy have enabled shorter treatment courses, smaller radiation
fields, prone positioning, and fewer side effects associated with breast cancer
treatment. To further improve target accuracy in breast radiation delivery, an emerging
radiotherapy technology takes advantage of on-table MRI imaging and daily adaptive
planning during the radiation delivery process.
The objectives of the study are to compare side effects in patients treated under either
of these treatment settings and to compare recurrence (if the cancer comes back) rates at
a 2-year time point. Patients will have annual follow ups up to 10 years and recurrence
rates will be measured at 5-year and at 10-year time points.
Criteria for eligibility:
Criteria:
Patients ≥ 50 yrs with histologically confirmed unilateral DCIS or Stage I invasive
breast cancer; received breast conserving surgery (pN0 or pNx) with tumor pathology ≤ 2
cm and excision margin ≥ 1 mm
Inclusion Criteria:
- Women status post segmental mastectomy
- If unilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised
with negative margins.
- If bilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised
with negative margins.
- Clinically N0 or pN0 or sentinel node negative
- Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
Exclusion Criteria:
- Previous radiation therapy to the ipsilateral breast.
- > 90 days from last surgery, unless s/p adjuvant chemotherapy
- > 60 days from last chemotherapy
- Patients unable to tolerate MRI or are otherwise unsuitable for MRI-based RT
treatment
- Metastatic disease
Gender:
Female
Gender based:
Yes
Minimum age:
50 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Weill Cornell Medicine
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lhaden Tshering, B.S.
Phone:
646-962-3118
Email:
lht4002@med.cornell.edu
Contact backup:
Last name:
Sharanya Chandrasekhar, M.S.
Phone:
646-962-3110
Email:
shc2043@med.cornell.edu
Investigator:
Last name:
John Ng, M.D.
Email:
Principal Investigator
Start date:
April 3, 2023
Completion date:
December 2028
Lead sponsor:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Source:
Weill Medical College of Cornell University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05731791
