Longterm Functional Outcomes in Patients Undergoing Organ Preserving Treatment for Rectal Cancer With or Without Local Excision After Chemoradiotherapy - Trial NCT06249672

Timeline & Enrollment

Primary Outcome

Low anterior resection syndrome

Summary

Treatment of rectal cancer by standard neoadjuvant chemoradiotherapy protocols leads to a
 complete response in about 15% of patients, or even a higher fraction if radiotherapy is
 followed by an Oxaliplatin based chemotherapy as published recently.
 
 If patient presents with a (near) complete response at the time of restaging after
 neoadjuvant treatment, an organ preservation strategy can be an alternative treatment to low
 anterior resection or abdominoperineal excision of the rectum. An organ preserving strategy
 is an ideal option for patients that are too frail for a major oncological resection.
 Furthermore, organ preservation is increasingly an option for a broader spectrum of patients
 as there is growing evidence that it allows to avoid surgical risks, including major
 dysfunction of the urinary, sexual and anorectal function at equivalent oncological outcomes.
 
 Studies investigating organ preserving rectal cancer treatment can broadly be divided into
 two categories. The first option is a planned local resection of the remaining scar at the
 site of the tumor after chemoradiotherapy. This can be achieved by direct transanal resection
 in very low tumors or by an endoscopic procedure as TEM (transanal endoscopic microsurgery)
 or TAMIS (trans-anal minimally invasive surgery). The advantage of this approach is the
 resulting pathological diagnosis which can confirm the complete response microscopically or
 indicate if there is remnant tumor tissue left and whether this is completely removed.
 However, local resection might have an additional negative functional impact and cumulate
 with function impairment from chemoradiotherapy.
 
 Alternatively, patients after complete clinical response can directly enter a surveillance
 programme without excision of the remaining scar after neoadjuvant treatment. This strategy
 provides less certainty about the complete regression of the primary tumor, but allows a
 treatment completely without surgical interventions and might lead to an even better
 functional outcome compared to patients undergoing local excision.
 
 There is good evidence that the influence of chemoradiotherapy on anorectal and genitourinary
 function is relevant. However there is lack of good quality data how much local excision adds
 to this impairment on the long run. In this study the investigator aims to compare functional
 outcomes and subjective treatment satisfaction in patients undergoing organ preserving
 treatment for rectal cancer with and without local resection after chemoradiotherapy. This
 data will help patients and healthcare personal to choose between these treatment options in
 the future, knowing the difference in functional outcome between the groups.
 
 As this is an observational study, there will not be any influence on treatment decisions for
 the included subjects. Clinical data will be collected by questionnaires and compared between
 the two cohorts, which is in line with a risk category A according to HRO (Human Research
 Ordinance).

ICD-10 Classifications