Rectal Cancer
Conditions
Keywords
organ preservation
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.
Interventions
RADIATIONDose 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
Sponsors
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two year TME-free survival | Two years from the start of radiotherapy | Patients alive and without TME-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clincal complete response rate | three months after the end of radiotherapy | Patients who have no evidence of residual tumor on MRI and rectoscopy |
Countries
Germany
Contacts
CONTACTCihan Gani, MD
Outcome results
None listed