Intra-Operative Radiation Registry
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAlbert Einstein College of Medicine
About this trial
This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable partial breast irradiation (PBI) per the latest American Society of Radiation Oncology (ASTRO) guidelines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female gender
Age ≥ 45
cT1-2N0, <3.5cm invasive breast cancer, estrogen-receptor positive or DCIS of breast, Grade 1-2, mammographically detected, < 2.5 cm, estrogen-receptor positive
Suitable for breast conserving surgery
Disqualifiers
Known axillary lymph node positive breast cancer (negative biopsy not required)
Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound, MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy.
Patients known to have BRCA 1/2 (breast cancer 1, breast cancer 2) gene
Patients undergoing neoadjuvant chemotherapy
Trial population
Patients enrolled on this study will be planned for lumpectomy with or without sentinel node biopsy for early stage breast cancer. Patients will be evaluated by a radiation oncologist who specializes in the treatment of breast cancer and will be deemed to be eligible for IORT. Patients with a history of ipsilateral cancer and/or prior in-field radiation are eligible, as IORT would likely be less toxic than repeat whole or partial breast external beam radiation and can allow patients to avoid mastectomy who wish to do so.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of patients with locally controlled disease
How many patients have recurrent disease following intra-operative radiation
Time frame
5 years following radiation therapy2
Number of patients with regionally controlled disease
How many patients have recurrent nodal disease following intra-operative radiation
Time frame
5 years following radiation therapy3
Number of patients with grade 2 or higher toxicities
How many patients have toxicity as measured by the CTCAE
Time frame
5 years following radiation therapySponsors and contacts
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Source ClinicalTrials.gov