Overview
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
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).