Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07337876

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

Led by University Hospital Tuebingen · Updated on 2026-02-17

100

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed rectal cancer located between the dentate line and 12 cm from the anocutaneous line
  • MRI staged rectal cancer with cT1 to cT3 and cN0 to cN1, and no distant metastases (cM0)
  • UICC Stage I tumors included only if unsuitable for endoscopic resection or if surgery would require permanent colostomy or poor organ function
  • Tumor involves less than 70% of rectal circumference
  • Tumor longitudinal extension less than 8 cm on MRI
  • High-resolution, thin-sliced MRI (≤3mm) of the pelvis required
  • Cross-sectional imaging of abdomen and chest to exclude distant metastases
  • Age 18 years or older, no upper age limit
  • WHO/ECOG Performance Status of 0 or 1
  • Adequate blood, liver, kidney, and metabolic function
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Tumor lower border more than 12 cm from the anocutaneous line measured by rigid rectoscopy
  • Presence of distant metastases
  • Preexisting fecal incontinence for solid stool
  • Prior antineoplastic therapy for rectal cancer
  • Prior pelvic radiotherapy
  • Pregnant or breastfeeding, or planning pregnancy within 6 months after treatment
  • Unwillingness to use effective contraception during treatment and for 6 months after
  • Concurrent other antineoplastic therapy
  • Serious concurrent diseases including neurological or psychiatric disorders, uncontrolled infections, or coagulation disorders
  • Other primary tumors with life expectancy less than three years
  • Contraindications to 5-Fluorouracil or Capecitabine
  • Psychological, familial, social, or geographic conditions that may interfere with compliance or follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany, 72074

Actively Recruiting

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Research Team

C

Cihan Gani, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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