Intra-Operative Radiation Registry

NCT04994067 | Recruiting

• 1 other identifier: 2018-9409
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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 partial breast irradiation (PBI) per the latest American Society of Radiation Oncology (ASTRO) guidelines.

Conditions

Breast Cancer

Keywords

intraoperative radiation therapy; partial breast irradiation

Outcome Measures

Primary Outcomes (3)

• Number of patients with locally controlled disease

  How many patients have recurrent disease following intra-operative radiation

  5 years following radiation therapy

• Number of patients with regionally controlled disease

  How many patients have recurrent nodal disease following intra-operative radiation

  5 years following radiation therapy

• Number of patients with grade 2 or higher toxicities

  How many patients have toxicity as measured by the CTCAE

  5 years following radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467-2490, United States

RECRUITING

Related Publications (11)

• Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.

  PMID: 16360786 BACKGROUND

• Smith TE, Lee D, Turner BC, Carter D, Haffty BG. True recurrence vs. new primary ipsilateral breast tumor relapse: an analysis of clinical and pathologic differences and their implications in natural history, prognoses, and therapeutic management. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1281-9. doi: 10.1016/s0360-3016(00)01378-x.

  PMID: 11121624 BACKGROUND

• Polgar C, Fodor J, Major T, Nemeth G, Lovey K, Orosz Z, Sulyok Z, Takacsi-Nagy Z, Kasler M. Breast-conserving treatment with partial or whole breast irradiation for low-risk invasive breast carcinoma--5-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):694-702. doi: 10.1016/j.ijrobp.2007.04.022. Epub 2007 May 25.

  PMID: 17531400 BACKGROUND

• King TA, Bolton JS, Kuske RR, Fuhrman GM, Scroggins TG, Jiang XZ. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T(is,1,2) breast cancer. Am J Surg. 2000 Oct;180(4):299-304. doi: 10.1016/s0002-9610(00)00454-2.

  PMID: 11113440 BACKGROUND

• Vicini FA, Baglan KL, Kestin LL, Mitchell C, Chen PY, Frazier RC, Edmundson G, Goldstein NS, Benitez P, Huang RR, Martinez A. Accelerated treatment of breast cancer. J Clin Oncol. 2001 Apr 1;19(7):1993-2001. doi: 10.1200/JCO.2001.19.7.1993.

  PMID: 11283132 BACKGROUND

• Kaufman SA, DiPetrillo TA, Price LL, Midle JB, Wazer DE. Long-term outcome and toxicity in a Phase I/II trial using high-dose-rate multicatheter interstitial brachytherapy for T1/T2 breast cancer. Brachytherapy. 2007 Oct-Dec;6(4):286-92. doi: 10.1016/j.brachy.2007.09.001.

  PMID: 17991625 BACKGROUND

• Arthur DW, Winter K, Kuske RR, Bolton J, Rabinovitch R, White J, Hanson WF, Wilenzick RM, McCormick B. A Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: tumor control and survival outcomes of RTOG 95-17. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):467-73. doi: 10.1016/j.ijrobp.2007.12.056. Epub 2008 Mar 4.

  PMID: 18294778 BACKGROUND

• Rabinovitch R, Winter K, Kuske R, Bolton J, Arthur D, Scroggins T, Vicini F, McCormick B, White J. RTOG 95-17, a Phase II trial to evaluate brachytherapy as the sole method of radiation therapy for Stage I and II breast carcinoma--year-5 toxicity and cosmesis. Brachytherapy. 2014 Jan-Feb;13(1):17-22. doi: 10.1016/j.brachy.2013.08.002. Epub 2013 Sep 14.

  PMID: 24041956 BACKGROUND

• Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.

  PMID: 28779963 BACKGROUND

• Veronesi U, Orecchia R, Maisonneuve P, Viale G, Rotmensz N, Sangalli C, Luini A, Veronesi P, Galimberti V, Zurrida S, Leonardi MC, Lazzari R, Cattani F, Gentilini O, Intra M, Caldarella P, Ballardini B. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial. Lancet Oncol. 2013 Dec;14(13):1269-77. doi: 10.1016/S1470-2045(13)70497-2. Epub 2013 Nov 11.

  PMID: 24225155 BACKGROUND

• Vaidya JS, Wenz F, Bulsara M, Tobias JS, Joseph DJ, Keshtgar M, Flyger HL, Massarut S, Alvarado M, Saunders C, Eiermann W, Metaxas M, Sperk E, Sutterlin M, Brown D, Esserman L, Roncadin M, Thompson A, Dewar JA, Holtveg HM, Pigorsch S, Falzon M, Harris E, Matthews A, Brew-Graves C, Potyka I, Corica T, Williams NR, Baum M; TARGIT trialists' group. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet. 2014 Feb 15;383(9917):603-13. doi: 10.1016/S0140-6736(13)61950-9. Epub 2013 Nov 11.

  PMID: 24224997 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jana Fox, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Fox, MD

CONTACT

718-920-4140; jfox@montefiore.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: August 9, 2018
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 1, 2032
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)