Intra-Operative Radiation Registry

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04994067
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

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 PBI per the latest ASTRO guidelines.

Detailed Description

Eligible patients will be referred for radiation oncology consultation by the operating surgeon. Patients will be presented with all radiation options and if they choose IORT, they will be offered enrollment onto the registry trial and consented accordingly. The registry will collect treatment data from the operation, radiation and pathology notes post IORT for each patient enrolled. Sources of research material, i.e. resected breast tissue and lymph nodes, will be obtained as part of routine clinical care. No additional tissue will be collected from patients due to enrollment on this registry trial. No additional studies will be performed outside of the routine standard of care.

Post treatment, the registry will collect data based on the standard of care follow up schedule. Follow-up visits will be scheduled 2-3 weeks post-operatively, as per standard of care, to review the final pathology and for the initial toxicity assessment. Patients found to have positive margins and/or lymph node involvement may require further surgery and/or additional external beam radiation. Additional follow-up visits with radiation oncology will be scheduled at 6 months and 1, 2, 3, 4, and 5 years following IORT. Toxicity will be scored using CTCAE v4.03. Local control will be evaluated using clinical exam and semi-annual to annual mammograms. All such information will be tracked and recorded into the registry database.

Study Timeline

• Study Start: 2018-08-09
• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• 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
• No contraindication to radiation
• Mammogram within 6 months of planned procedure
• Fitness for lumpectomy under general anesthesia
• Planned to receive IORT

Exclusion criteria

• 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with regionally controlled disease	5 years following radiation therapy	How many patients have recurrent nodal disease following intra-operative radiation
Number of patients with grade 2 or higher toxicities	5 years following radiation therapy	How many patients have toxicity as measured by the CTCAE
Number of patients with locally controlled disease	5 years following radiation therapy	How many patients have recurrent disease following intra-operative radiation

Trial Locations

Locations (1)

Montefiore Medical Center - Moses Campus; 🇺🇸 Bronx, New York, United States