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The Rectal Applicator is designed to deliver high dose rate (HDR) brachytherapy for patients with rectal cancer. This single-use applicator is compatible with Elekta’s Flexitron and microSelectron afterloader systems.
Not available in all markets
Single-use applicator, ensuring patient safety
Offering maximum flexibility to minimize patient discomfort.
Easy to use in current clinical workflows
Option to choose from inpatient and outpatient care
The Easy Click System is designed to make assembly of the Fixation Element simple, no screws or screwdriver is needed. The Fixation Element and Fixation Clip, as well as the Insertion Tool, are reusable and can be sterilized by steam sterilization.
The applicator is suitable for use in an MR environment, and provides good imaging results without artifacts or distortion when used with x-ray and CT.
The applicator’s length markings help the user identify insertion depth and confirm that the applicator has not shifted after insertion. In addition, radiopaque catheters help users to locate twists during reconstruction.
High dose rate (HDR) brachytherapy is an attractive alternative to surgery. See the evidence yourself.
High dose rate (HDR) brachytherapy is an attractive alternative to surgery (total mesorectal excision [TME]) for patients with rectal cancer, helping them avoid the quality of life detractors associated with TME. HDR brachytherapy also is desirable to EBRT alone, which uses a lower therapeutic dose and a higher risk of radiation side effects in organs-at-risk, such as the prostate, bladder and small bowel.
HDR brachytherapy is based on tumor imaging, typically with MRI, which is used to select suitable patients and improve tumor visualization. 3D CT simulation is used for treatment planning, and this outpatient therapy is delivered with a rectal applicator and requires minimal local anesthesia.1 Preoperatively, HDR brachytherapy, alone or combined with EBRT, has provided superior pathological complete response rates versus EBRT as a monotherapy.1-2
With its greater conformality to the target, HDR brachytherapy permits better sparing of adjacent healthy tissues during treatment, while delivering higher doses to the tumor.3 This decreases the number and severity of side effects (e.g., perioperative bleeding, proctitis, ulceration, bleeding, fistula formation) and results in a more effective treatment. 1-2, 4
With advanced imaging modalities – such as CT or MRI – for enhanced tumor visualization and for treatment planning, HDR brachytherapy is safe and effective in achieving a high tumor regression rate and was well tolerated in a phase II multicenter and two matched-pair studies.4
The modality is presently investigated as a phase III dose-escalation study in the nonoperative management (NOM) of patients with operable rectal cancer.4
The aim of this study is to validate HDR brachytherapy’s value for patients with operable stage II rectal cancer. The preliminary interim toxicity analysis of the first 40 patients showed favorable toxicity post-operative data and potential benefits from HDR brachy boost in the NOM of rectal cancer. Patients were randomized to receive either an EBRT boost of 9 Gy in five fractions (Arm A) or three weekly adaptive brachytherapy boosts totaling 30 Gy (Arm B). There was a 50 percent complete clinical response (Arm A) and 90 percent complete clinical response (Arm B).5
The 2023 phase III OPERA trial suggests that in selected patients with cT2-cT3a/b tumors in the distal-middle rectum, < 5cm in diameter with negative nodes or cN1 with lymph nodes < 8 cm diameter, a treatment approach to achieve organ preservation using neoadjuvant chemoradiotherapy and a contact x-ray brachytherapy boost should be discussed as a valid option within the multidisciplinary team. Greater availability of contact x-ray brachytherapy machines and training of radiation oncologists in their use is mandatory to enable adoption and expansion of this approach.6
References
1. Vuong T, Devic S. High-dose-rate pre-operative endorectal
brachytherapy for patients with rectal cancer. J Contemp
Brachytherapy. 2015 Apr;7(2):183-8. doi: 10.5114/jcb.2015.51402.
Epub 2015 May 6. PMID: 26034500; PMCID: PMC4444460.
2. Buckley H, Wilson C, Ajithkumar T (2017) High-dose-rate
brachytherapy in the management of operable rectal cancer: a
systematic review. Int J Radiat Oncol Biol Phys 99(1):111–127.
https://doi.org/10.1016/j.ijrobp.2017.05.023
3. Tam SY, Wu VWC (2019) A review on the special radiotherapy
techniques of colorectal cancer. Front Oncol 9:208.
https://doi.org/10.3389/fonc.2019.00208
4. Vuong T, Garant A, Vendrely V, et al. Image-Guided
Brachytherapy for Rectal Cancer: Reviewing the Past Two Decades
of Clinical Investigation. Cancers (Basel). 2022 Oct
4;14(19):4846. doi: 10.3390/cancers14194846. PMID: 36230770;
PMCID: PMC9563024.
5. Garant A, Vasilevsky CA, Boutros M, et al. MORPHEUS Phase
II-III Study: A Pre-Planned Interim Safety Analysis and
Preliminary Results. Cancers (Basel). 2022 Jul 28;14(15):3665.
doi: 10.3390/cancers14153665. PMID: 35954329; PMCID:
PMC9367346.
6. Gerard J-P, Barbet N, Schiappa R, et al. Neoadjuvant
chemoradiotherapy with radiation dose escalation with contact
x-ray brachytherapy boost or external beam radiotherapy boost
for organ preservation in early cT2–cT3 rectal adenocarcinoma
(OPERA): a phase 3, randomised controlled trial. Published:
February 16, 2023.
https://www.thelancet.com/journals/langas/article/PIIS2468-1253(22)00392-2/fulltext.
Patient in
Applicator insertion
Imaging
Treatment Planning
Treatment Delivery
Patient out
Applicator Disposal
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Rectal Applicator is processing CE mark and not available commercially.