This document replaces previous guidance on preoperative high dose rate brachytherapy for rectal cancer (interventional procedure guidance 201).
1.1 Current evidence on the safety of preoperative high dose rate brachytherapy for rectal cancer and its efficacy in reducing tumour size appears adequate. However, there is no evidence that the procedure provides additional benefit when used as a boost to external beam radiotherapy. Evidence on the clinical efficacy of the procedure if used without external beam radiotherapy is inadequate in quantity. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to do preoperative high dose rate brachytherapy for rectal cancer should take the following actions:
Inform the clinical governance leads in their NHS trusts.
Ensure that patients understand the uncertainty about the procedure's efficacy and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
Audit and review clinical outcomes of all patients having preoperative high dose rate brachytherapy for rectal cancer (see section 7.2).
1.3 Patient selection should be done by a colorectal cancer multidisciplinary team which includes a clinical oncologist and a colorectal surgeon with expertise in local excision techniques.
1.4 NICE encourages further research into preoperative high dose rate brachytherapy for rectal cancer. Trials should be designed to provide clear data on the efficacy of this procedure, whether or not other adjunctive treatments are used. Research should document adjunctive treatments and details of patient selection. Outcomes should include local recurrence, survival, disease‑free survival and quality of life. NICE may update the guidance on publication of further evidence.