Colorectal Cancer Clinical Trials

Find Colorectal Cancer Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital Tübingen
RECRUITING
Tübingen
Contact Information
Primary
Cihan Gani, MD
cihan.gani@med.uni-tuebingen.de
+4970712982165
Time Frame
Start Date: 2026-01-07
Estimated Completion Date: 2029-01
Participants
Target number of participants: 100
Treatments
Experimental: MR guided dose escalated radiotherapy
A dose of 65 Gy is delivered to the primary tumor and affected lymph nodes.
Related Therapeutic Areas
Sponsors
Leads: University Hospital Tuebingen

This content was sourced from clinicaltrials.gov