Clinical trials

UCL CTG

18 February 2014

The Clinical Trials Group (CTG) is a specialist clinical trials unit contained within the UCL Division of Surgery and Interventional Science, which in turn is part of the School of Life and Medical Sciences of University College London. The research portfolio of the CTG can be traced back to its inception in 1981, and since then over 32, 000 patients have been recruited into studies run by the group; all studies have been published in high-ranking journals and many having directly changed clinical practice.

Trials run by the CTG tend to involve medical devices, and tend to be surgeon-led. The CTG is an academic Group, but also has experience in running trials in collaboration with industry.

There is a suite of TARGIT clinical studies in progress or planned; there follows a summary. 

TARGIT A (alone)

An international multicentre randomised controlled trial (ISRCTN34086741) designed to determine non-inferiority between the TARGIT technique and conventional external beam radiotherapy (EBRT) in women with early breast cancer. IORT is given as a single dose of 20 Gy at the surface of the applicator (equivalent to 6 Gy at 1 cm) to the tumour bed under direct observation. The primary outcome measure is local relapse within the treated breast; secondary endpoints are site of relapse within the breast, relapse-free and overall survival, and local toxicity and/or morbidity. Early results show the technique is safe: the frequency of any complications and major toxicity was similar in the two groups (for major toxicity, TARGIT 37 [3.3%] of 1113 vs EBRT 44 [3.9%] of 1119; p=0.44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the TARGIT group (0.5%) than in the EBRT group (2.1%; p=0.002). In terms of efficacy, the 5-year risk for local recurrence in the conserved breast when TARGIT was given concurrently with lumpectomy (n=2298) had much the same results as EBRT: 2.1% (1.1-4.2) versus 1.1% (0.5-2.5; p=0.31). The TARGIT A trial continues in follow-up of patients.

TARGIT B (boost)

This study (ISRCTN43138042) is a multicentre randomised controlled trial that began accrual in 2013 testing the replacement of the EBRT boost to the tumour bed by a TARGIT boost given during surgery; all patients will receive EBRT. The target population is women with breast cancer who have a high risk of local recurrence. Specifically, patients should be either younger than 45 or, if older, need to have pathological features that confer a high risk of local recurrence of breast cancer, such as lymphovascular invasion, gross nodal involvement (not micrometastasis), more than one tumour in the breast but still suitable for breast-conserving surgery through a single specimen, ER negative, grade 3 histology or positive margins at first excision. This trial is based on results from a phase II non-randomised study of 299 unselected patients who had breast-conserving surgery and IORT as a boost to the tumour bed. The treatment was well tolerated. After a median follow up of 60.5 months, eight patients had an ipsilateral recurrence, which gave a 5-year Kaplan-Meier estimate for ipsilateral recurrence of 1.73% (SE 0.77).

Both TARGIT A and B are run by the UCL CTG.

TARGIT E (elderly)

A prospective phase II study of IORT in elderly patients being run by Professor Wenz in the University Hospital Mannheim.

TARGIT BQR (boost quality-control registry)

As the name implies, a registry of patients treated by TARGIT as a boost, again being run by Professor Wenz.

TARGIT US

A registry trial of TARGIT being run in the USA.