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

NCT ID: NCT07337876

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-07
• Study Completion Date: 2029-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MR guided dose escalated radiotherapy

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

Group Type: EXPERIMENTAL

Dose escalated radiotherapy using a 1.5 T MR-Linac

Intervention Type: 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

Interventions

Dose escalated radiotherapy using a 1.5 T MR-Linac

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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
• Inclusion of UICC Stage I tumors only if unsuitable for endoscopic resection or if primary surgery would require permanent colostomy or deep anastomosis with expected poor organ function.
• 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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Dr. Cihan Gani

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

Central Contacts

Cihan Gani, MD

Role: CONTACT

cihan.gani@med.uni-tuebingen.de

+4970712982165

Other Identifiers

311/2025BO1

Identifier Type: -

Identifier Source: org_study_id