Short course radiotherapy versus chemoradiotherapy, followed by consolidation chemotherapy, and selective organ preservation for MRI-defined intermediate and high-risk rectal cancer patients, A randomized phase III trial of the German Rectal Cancer Study Group

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511577-29-01

Acronym

ACO/ARO/AIO-18.1

Enrollment

688

Registered

2024-09-26

Start date

2020-03-13

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intermediate and high-risk rectal cancer

Brief summary

The primary endpoint of this trial, organ preservation, is defined as follows: survival with rectum intact, no major surgery, no stoma.

Detailed description

Disease-free survival, Rate of clinical complete response after TNT, Rate of immediate TME after TNT, Cumulative incidence of locoregional regrowth after cCR, Rate of salvage surgery (LE/TME with or without APR/stoma) after locoregional regrowth, Cumulative incidence of local recurrence after (salvage) surgery, Postoperative complications of (salvage) surgery, Rate of sphincter-sparing (salvage) surgery, Pathological TNM-staging, R0 resection rate; negative circumferential resection rate, Tumor regression grading according to Dworak, Neoadjuvant rectal score, Quality of TME according to MERCURY, Acute and late toxicity assessment according to NCI CTCAE V.5.0), Quality of life and functional outcome based on treatment arm and surgical procedures/organ preservation, Cumulative incidence of distant metastases, Overall survival, Translational / biomarker studies

Interventions

DRUGCalciumfolinat-GRY® 100 mg/10 ml Injektionslösung

DRUGXeloda 500 mg film-coated tablets

DRUGCalciumfolinat-GRY® 500 mg/50 ml Injektionslösung

DRUGOxaliplatin Accord 5 mg/ml

DRUGKonzentrat zur Herstellung einer Infusionslösung

DRUGXeloda 150 mg film-coated tablets

DRUGCalciumfolinat-GRY® 300 mg/30 ml Injektionslösung

DRUG5-FU medac 50 mg/ml

DRUGInjektionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this trial, organ preservation, is defined as follows: survival with rectum intact, no major surgery, no stoma.	—

Secondary

Measure	Time frame
Disease-free survival, Rate of clinical complete response after TNT, Rate of immediate TME after TNT, Cumulative incidence of locoregional regrowth after cCR, Rate of salvage surgery (LE/TME with or without APR/stoma) after locoregional regrowth, Cumulative incidence of local recurrence after (salvage) surgery, Postoperative complications of (salvage) surgery, Rate of sphincter-sparing (salvage) surgery, Pathological TNM-staging, R0 resection rate; negative circumferential resection rate, Tumor regression grading according to Dworak, Neoadjuvant rectal score, Quality of TME according to MERCURY, Acute and late toxicity assessment according to NCI CTCAE V.5.0), Quality of life and functional outcome based on treatment arm and surgical procedures/organ preservation, Cumulative incidence of distant metastases, Overall survival, Translational / biomarker studies	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026