RecruitingNot ApplicableNCT05772923

Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision

Organ Preservation in Patients With a Good Clinical Response After (Chemo)Radiation for Rectal Cancer: Defining the Role of Additional Contact X-ray Brachytherapy Versus Extending the Waiting Interval and Local Excision

Sponsor

The Netherlands Cancer Institute

Enrollment

168 participants

Start Date

Apr 16, 2021

Study Type

INTERVENTIONAL

Conditions

Quality of Life Rectal Cancer Locally Advanced Rectal Carcinoma Organ Preservation

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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;
technically feasible to perform both treatment options (contact x-ray brachytherapy or local excision);
age \>18 years;
written informed consent.

Exclusion Criteria6

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;
patients who are unable to undergo contact x-ray brachytherapy or local excision;
patients who cannot tolerate a completion- or salvage-TME because of comorbidity or frailty;

Interventions

RADIATIONContact x-ray brachytherapy

With 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.

PROCEDURELocal excision

Local excision will basically be performed by the TAMIS-procedure (transanal minimally invasive surgery).