# TARGIT-A (targeted intraoperative radiotherapy)

Source: https://onco.cc/trials/targit-a/  
OnCo record `targit-a` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

One dose of radiotherapy given inside the breast while the patient is still asleep, instead of three to six weeks of daily hospital visits. Cancer control was close enough to count as equivalent, slightly more cancers came back in the breast, and fewer women died of causes other than breast cancer.

## Summary

TARGIT-A randomised 2,298 women aged 45 or over with invasive ductal carcinoma up to 3.5 cm at 32 centres in ten countries between 2000 and 2012, before lumpectomy, to risk-adapted targeted intraoperative radiotherapy or to external beam radiotherapy. Intraoperative treatment was delivered immediately after the lumpectomy under the same anaesthetic and was the only radiotherapy about 80 percent of those patients received; the remaining fifth had external beam treatment added when postoperative pathology found unsuspected higher-risk features.

The trial met its non-inferiority margin of 2.5 percent: local recurrence risk at five years with complete follow-up was 2.11 percent with intraoperative treatment against 0.95 percent with external beam, a difference of 1.16 percent (90 percent confidence interval 0.32 to 1.99). In the first five years there were thirteen more local recurrences (24 of 1,140 against 11 of 1,158) and fourteen fewer deaths (42 against 56).

At a median 8.6 years, nothing separated the arms on local recurrence-free survival (hazard ratio 1.13, 95 percent confidence interval 0.91 to 1.41, p=0.28), mastectomy-free survival (0.96, 0.78 to 1.19, p=0.74), distant disease-free survival (0.88, 0.69 to 1.12, p=0.30), overall survival (0.82, 0.63 to 1.05, p=0.13) or breast cancer mortality (1.12, 0.78 to 1.60, p=0.54). One endpoint did separate them: mortality from other causes was lower with intraoperative treatment (0.59, 0.40 to 0.86, p=0.005), which the investigators attribute to sparing the heart and lung.

England did not adopt it. NICE TA501, published on 31 January 2018, recommends that the Intrabeam system is not used for routine commissioning, and permits it only on machines already installed and under NHS England clinical governance and data collection arrangements. The record is marked mixed because the trial met its own margin while the regulator that read it declined to fund the device.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-25
- Also known as: TARGIT-A trial; TARGIT-IORT; Intrabeam trial
- Registry id: NCT00983684
- Phase: 3
- Setting: Women aged 45 or over with invasive ductal carcinoma up to 3.5 cm, cN0 to cN1, eligible for breast conservation: a single dose of targeted intraoperative radiotherapy given during lumpectomy, with external beam radiotherapy added where pathology found higher risk, against a standard course of whole-breast external beam radiotherapy
- Sponsor: University College London
- Enrolled: 2298
- Result: Five-year local recurrence 2.11 percent with single-dose intraoperative radiotherapy against 0.95 percent with external beam, meeting the 2.5 percent non-inferiority margin; at a median 8.6 years no difference in survival, and mortality from other causes lower (hazard ratio 0.59, 0.40 to 0.86).
- Outcomes: Local recurrence at 5 years: Targeted intraoperative radiotherapy 2.11% vs External beam radiotherapy 0.95%; Overall survival, long-term follow-up (median 8.6 years): Targeted intraoperative radiotherapy against external beam 0.82 hazard ratio, HR 0.82; Mortality from causes other than breast cancer: Targeted intraoperative radiotherapy against external beam 0.59 hazard ratio, HR 0.59

## Sources

- ClinicalTrials.gov NCT00983684: https://clinicaltrials.gov/study/NCT00983684
- ISRCTN34086741: https://www.isrctn.com/ISRCTN34086741
- TARGIT-A long-term results (BMJ 2020): https://doi.org/10.1136/bmj.m2836
- NICE TA501: Intrabeam radiotherapy system, not recommended for routine commissioning: https://www.nice.org.uk/guidance/ta501

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/), [Intraoperative radiotherapy (IORT)](https://onco.cc/technologies/intraoperative-radiotherapy/)
- institutions: [University College London Hospitals / UCL Cancer Institute](https://onco.cc/institutions/uclh/)
- terms: [Lumpectomy (breast-conserving surgery)](https://onco.cc/terms/lumpectomy/), [Partial-breast irradiation](https://onco.cc/terms/partial-breast-irradiation/)
- trials: [IMPORT LOW](https://onco.cc/trials/import-low/), [NSABP B-39/RTOG 0413](https://onco.cc/trials/nsabp-b39/), [RAPID (accelerated partial-breast irradiation)](https://onco.cc/trials/rapid/)
- key papers: [Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial](https://onco.cc/key-papers/paper-vaidya-bmj/)

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