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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    1 Recommendations

    Early-stage and locally advanced rectal cancer

    1.1

    Low-energy contact X-ray brachytherapy can be used as an option to treat early-stage and locally advanced rectal cancer in people when either:

    • the person chooses not to have surgery and their tumour:

      • is 3 cm or less and

      • has not spread beyond stage T3b or N1 (with limited nodal involvement), or

    • surgery is not suitable.

      People with larger tumours (with limited nodal involvement) may become eligible for this procedure if neoadjuvant treatment reduces the tumour to 3 cm or less.

    Advanced rectal cancer

    1.2

    More research is needed on low-energy contact X-ray brachytherapy to treat advanced rectal cancer in people before it can be used in the NHS.

    1.3

    For people with advanced rectal cancer, this procedure should only be done as part of formal research and a research ethics committee needs to have approved its use.

    What research is needed

    More research, in the form of randomised controlled trials, in people with advanced rectal cancer is needed on:

    • patient selection including tumour type and suitability for surgery

    • treatment intent

    • patient-reported outcomes

    • survival

    • organ preservation (the rectum and surrounding structures remain intact and functioning)

    • quality of life

    • long-term outcomes.

    What this means in practice

    Early-stage and locally advanced rectal cancer

    There is enough evidence on the safety and efficacy of this procedure for clinicians to consider low-energy contact X-ray brachytherapy as an option for early-stage and locally advanced rectal cancer.

    Clinicians should always discuss the available options with the person with rectal cancer before a joint decision is made (see NICE's page on shared decision making).

    Hospital trusts will have their own policies on funding procedures and getting permission to do operations and monitoring results. NHS England may also have policies on funding of procedures.

    Advanced rectal cancer

    There is not enough evidence to know if this procedure is safe and effective for advanced rectal cancer. Low-energy contact X-ray brachytherapy should only be done as part of formal research.

    Auditing of outcomes

    Clinicians doing this procedure should collect data on safety and outcomes of the procedure. Enter details about everyone having this procedure into the ColoRectal database (CR-DB) and regularly review the data on outcomes and safety.

    Who should be involved in the procedure

    Patient selection should be done by a colorectal cancer multidisciplinary team that includes a clinical oncologist and a colorectal surgeon with specific training in this procedure and expertise in local excision techniques. The procedure should only be done in centres specialising in managing rectal cancer.

    Why the committee made these recommendations

    Clinical trial evidence including randomised controlled trials and observational studies show that, in people with early-stage or locally advanced rectal cancer, low-energy CXB can achieve long-term disease control and is more likely to preserve the rectum and surrounding structures than surgery. Because radical surgery is avoided, patients may not need a permanent stoma. This substantially improves their quality of life.

    For people with advanced rectal cancer, there is not enough evidence on the efficacy and safety of the procedure. So, it should only be done in research.