ACO/ARO/AIO-18.1: Short-course radiotherapy versus chemoradiotherapy, followed by consolidation chemotherapy, and selective organ preservation for MRI-defined intermediate and high-risk rectal cancer patientsA randomized phase III trial of the German Rectal Cancer Study Group - ACO/ARO/AIO-18.1

niversity Hospital Frankfurt, Goethe University0 sites702 target enrollmentOctober 8, 2019

Overview

No summary available.

Registry

who.int

Start Date

October 8, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospital Frankfurt, Goethe University

•Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 – 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum).
•Staging requirements: High\-resolution, thin\-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
•MRI\-defined inclusion criteria: presence of at least one of the following high\-risk conditions:
•oany cT3 if the distal extent of the tumor is \< 6 cm from the anocutaneous line, or
•ocT3c/d in the middle third of the rectum (\= 6\-12 cm) with MRI evidence of extramural tumor spread into the mesorectal fat of more than 5 mm (\>cT3b), or
•ocT3 with clear cN\+ based on strict MRI\-criteria (see appendix)
•ocT4 tumors, or
•oTany middle/low third of rectum with clear MRI criteria for N\+
•omrCRM\+ (\= 1mm), or
•oExtramural venous invasion (EMVI\+).

•Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy.
•Distant metastases (to be excluded by CT scan of the thorax and abdomen).
•Prior antineoplastic therapy for rectal cancer.
•Prior radiotherapy of the pelvic region.
•Major surgery within the last 4 weeks prior to inclusion.
•Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
•Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
•On\-treatment participation in a clinical study in the period 30 days prior to inclusion.
•Previous or current drug abuse.
•Other concomitant antineoplastic therapy.