Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04088435 |
| Other study ID # |
19-0448 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 10, 2019 |
| Est. completion date |
June 5, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
University of Louisville |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI)
in which radiation therapy is delivered to the breast tissue in a single treatment at the
time of lumpectomy for breast cancer. The Xoft device (Axxent, Xoft, San Jose, CA) is a
device that allows for IORT for breast cancer using kilovoltage (kV) photons. A central goal
of this study is to report acute and late toxicities and cosmetic outcomes following breast
IORT with the Xoft device in women with early-stage breast cancer treated with lumpectomy.
The investigators hypothesize that IORT following lumpectomy will be safe and well tolerated
with a lower rate of physician reported acute side effects than traditional whole breast
radiation therapy after lumpectomy.
Description:
Details of Radiation Therapy: Both breast conserving surgery and IORT will be delivered as
per standard practice. Lumpectomy and sentinel lymph node biopsy will be performed by the
breast surgeon using standard techniques and as per standard of care. IORT with Xoft Axxent
System will be given at the time of lumpectomy for early stage breast cancer. During the same
operative procedure, a single fraction of radiation will be given to the lumpectomy bed with
IORT. The Xoft Axxent treatment device size will be customized to the patient's anatomy based
on the volume of lumpectomy cavity. The prescription dose will be 20 Gy prescribed to the
surface of the lumpectomy cavity. Postoperative, external beam, whole breast radiation
therapy will be given that the discretion of the treating physician based on the presence of
high risk clinicopathologic features. Based on data from existing, published, clinical
trials, it is estimated that 15% of patients will require postoperative radiation in addition
to IORT. As with standard practice, all patients planned for IORT will be discussed pre- and
post-surgery at the breast cancer multidisciplinary conference for pathology and radiology
review.
Study outline: After patients complete lumpectomy and IORT, their acute and late toxicities
and cosmetic outcome will be monitored on protocol. Patients will complete clinical follow up
in radiation oncology at 4-6 weeks, 6 months, 1 year, 18 months, 2 years and then yearly for
a total of 5 years. In accordance with standard clinical practice, patients will have
toxicity assessment, physical exam, and cosmetic scoring by the physician. Physician toxicity
assessment will be performed with Common Terminology Criteriae for Adverse Events (CTCAE)
version 5.0, Late Effects Normal Tissue Task Force-Subjective, Objective, Management,
Analytic (LENT-SOMA), and Radiation Therapy Oncology Group (RTOG) skin and toxicity scales.
Physician cosmetic assessment will be performed with the Harvard Cosmetic Scale. Patients
will also be asked to complete Breast Cancer Treatment Outcome Scale (BCTOS) self-assessment
for patient reported cosmetic, functional and pain symptoms. Breast-Q version 2.0 will also
be used to evaluate patient-reported cosmetic outcome, physical well being and adverse
events.
A prospective database will be created and maintained. Patient data will be deidentified in
the database with patients assigned unique study codes. Their assigned study code will be
kept in a single encrypted file by the principal investigator.
This is an observational prospective study. To reduce selection bias, all eligible
consecutive patients will be enrolled. The investigators expect the sample size to be around
20 per year with a total of 60 in three years. Multiple adverse radiation outcomes (including
breast pain, radiation dermatitis, breast edema, seroma, infection) will be evaluated and
compared with historical controls to detect if prevalence differs by 20% and 16% in two- and
three-years accrual, respectively (n=40 in two years and n=60 in three years) at alpha=0.05
and power =80%.
Descriptive statistics (mean, median, standard deviation, minimum and maximum for continuous
measures, and frequency and percentages for ordinal measures) related to participant
characteristics, treatment and risk factors will be produced for the entire cohort and
subsets of cohort. Differences in adverse radiation effects in the IORT protocol participants
and historic controls will be assessed using the Cochran-Armitage test for trend or
chi-squared test, as appropriate. Univariate analysis will be used to detect associations
between cosmetic outcome and patient-specific and treatment-related factors by use of either
a chi-squared test (categorical variables) or t-test (continuous variables). The freedom from
ipsilateral breast tumor recurrence, progression free survival {PFS) and overall survival
(OS) will be estimated by the Kaplan-Meier method. Differences in survival between the
protocol cohort and historic controls will be evaluated through the estimated hazard rates
using the unweighted log-rank tests. PFS and OS will be estimated along with 95% precise
confidence intervals. In order to examine the significant factors, Cox proportional hazards
regression models will be used in both uni-variable and multi-variable settings. Other
factors to be analyzed are ethnicity, gender, age, and pathological subtype. The various
factors will be placed into categorical variables. Simple logistic regression will be used to
study association between a dichotomous outcome measure and any predictor. Once again, for
any dichotomous outcome measure, the effect of other covariates (as listed above) will also
be explored in addition to primary predictor using a multiple logistic regression analysis.
All results will be declared significant at significance level of 5%. Since there are
multiple outcomes compared, the investigators will adjust significance level for multiple
comparisons.
The investigators will maintain a prospectively collected database of patients who undergo
treatment, the details of which are kept in their electronic medical record. This EMR is
managed in the usual and customary manner throughout treatment and follow-up. An excel
spreadsheet of patients' MRN and their assigned study code will be kept in a single encrypted
file by the principal investigator. This encrypted file will remain on campus, secured in the
principal investigator's office, and held under lock and key.
