The goal of this prospective phase II feasibility study is to evaluate two additional local treatment options in rectal cancer patients with a good clinical response after neoadjuvant (chemo)radiation: contact x-ray brachytherapy versus extension of the waiting interval with or without local excision, and to investigate which rate of organ preservation can be achieved.
histologically verified adenocarcinoma above the dentate line and within 10cm of the anal verge;
neoadjuvant short-course radiotherapy for patients with 1) IRC and delayed response evaluation according to the Dutch national guidelines (cT1-3, cN1-2 lymph nodal status, no involved MRF or cT3c-d, N0-1 lymph nodal status without pres-ence of significant distant metastases) without full dose chemotherapy in the inter-val (e.g. Rapido-scheme) or 2) LARC due to comorbidity or frailty; OR
neoadjuvant long-course radiotherapy (chemoradiation) for patients with 1) LARC according to the Dutch national guidelines (cT4 tumour, cN2 lymph nodal status, lateral lymph node involvement, and/or involved MRF, without the presence of significant distant metastases) or 2) early rectal cancer or IRC and a strong wish for organ preservation;
clinically near-complete response or a small residual tumour mass <3 cm;
neoadjuvant or induction chemotherapy prior or adjacent to (chemo)radiation, e.g. patients with a Rapido or M1-scheme are not eligible;
radiation dose >50.4 Gy or boost dose on the primary tumour;
presence of suspicious lymph nodes (yN1/N2) at first response evaluation;
residual tumour ≥ 3cm or over half of the circumference of the rectal lumen;
Parallel
Contact x-ray brachytherapy
RadiationWith contact x-ray brachytherapy an intraluminal radiation boost up to 90 Gy is applied to the primary rectal tumour, with minimal collateral damage to the surrounding normal tissues due to minimal penetration of the 50 kVolt therapy.
Local excision
Procedure/SurgeryLocal excision will basically be performed by the TAMIS-procedure (transanal minimally invasive surgery).
Rate of successful organ preservation
Including an in-situ rectum (including patients subjected to local excision), no defunctioning stoma and absence of active loco-regional cancer failure (indicated as either local intraluminal tumour regrowth or regional recurrence in lymph nodes requiring TME-surgery)
Incidence of radiation toxicity
Frequency of adverse events grade 3-4 defined by the common terminology criteria of adverse events (CTCAE) version 5.0
Incidence of postoperative morbidity after local excision
Frequency of post-operative complication grade 3-4 according to Clavien-Dindo
Frequency of patients with a high Low Anterior Rectal Syndrome (LARS) score
Defined by the LARS questionnaire with a score between 30-42
Frequency of patients with impaired of bowel function
Defined by an approved questionnaire IL108 from the European Organization for Research and Treatment of Cancer (EORTC) based on selected items of EORTC QLQ-PR25, QLQ-CX24 and QLQ-ANL27
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The Netherlands Cancer Institute
Lead sponsor
Catharina Ziekenhuis Eindhoven
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
