Organ Preservation in Rectal Cancer by Dose Escalated MR Guided Adaptive Radiotherapy

NCT07337876 | Recruiting Phase 2

• 1 other identifier: 311/2025BO1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing whether radiation delivered with MRI guidance using a so-called MR-linac in distal rectal cancer can result in a high rate of organ preservation. Patients will receive radiotherapy together with standard chemotherapy.

Conditions

Rectal Cancer

Keywords

organ preservation

Outcome Measures

Primary Outcomes (1)

• Two year TME-free survival

  Patients alive and without TME-surgery

  Two years from the start of radiotherapy

Secondary Outcomes (1)

• Clincal complete response rate

  three months after the end of radiotherapy

Study Arms (1)

MR guided dose escalated radiotherapy

EXPERIMENTAL

A dose of 65 Gy is delivered to the primary tumor and affected lymph nodes.

Radiation: Dose escalated radiotherapy using a 1.5 T MR-Linac

Interventions

Dose escalated radiotherapy using a 1.5 T MR-Linac RADIATION

Dose escalated radiotherapy using a 1.5 T MR-Linac is given to the primary tumor and affected lymph nodes in an online adaptive manner

MR guided dose escalated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed diagnosis of rectal cancer localized between dentate line and 12 cm from the anocutaneous line
• Any MRI staged rectal cancer meeting the following criteria
• cT1-cT3 and
• cN0 -cN1 and
• cM0
• Tumor affects less than 70% of the rectal circumference.
• Maximum longitudinal extension of the tumor less than 8 cm on MRI
• MR-Staging requirements: High-resolution, thin-sliced (i.e.
• ≤3mm) magnetic resonance imaging (MRI) of the pelvis.
• Cross-sectional imaging of the abdomen and chest to exclude distant metastases.
• Aged at least 18 years. No upper age limit.
• WHO/ECOG Performance Status ≤ 1
• Adequate hematological, hepatic, renal and metabolic function parameters
• Informed consent of the patient

You may not qualify if:

• Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
• Distant metastases
• Preexisting fecal incontinence for solid stool
• Prior antineoplastic therapy for rectal cancer
• Prior radiotherapy of the pelvic region
• 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).
• Other concomitant antineoplastic therapy
• Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active,uncontrolled infections, active, disseminated coagulation disorder
• Other primary tumors with an estimated life expectancy of less than three years
• Contraindications for treatment with 5-Fluorouracil or Capecitabine
• Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72074, Germany

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Cihan Gani, MD

CONTACT

+4970712982165; cihan.gani@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 13, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

DE (1)