Organ preservation in locally advanced rectal cancer by radiochemotherapy followed by consolidation chemotherapy. A prospective phase II pilot trial of the German Rectal Cancer Study Group

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517928-19-00

Acronym

CAO/ARO/AIO-16

Enrollment

Registered

2024-10-11

Start date

2018-04-17

Completion date

2025-07-30

Last updated

2025-02-25

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

Conditions

Male and female patients with histologically confirmed diagnosis of rectal cancer

Brief summary

The primary objective of the present study is to estimate the clinical complete response rate after anintensified radiochemotherapy regimen in locally advanced rectal cancer. This clinical completeresponse determined in this study will be the basis for a consecutive study using the sameradiochemotherapy regimen with 2-year local control as endpoint.

Interventions

DRUGLeucovorin 10 mg/ml Lösung zur Injektion/ Infusion

DRUG5-FU medac 50 mg/ml

DRUGInjektionslösung

DRUGELOXATIN 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary objective of the present study is to estimate the clinical complete response rate after anintensified radiochemotherapy regimen in locally advanced rectal cancer. This clinical completeresponse determined in this study will be the basis for a consecutive study using the sameradiochemotherapy regimen with 2-year local control as endpoint.	—

Countries

Germany

Outcome results

None listed

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