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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR guided dose escalated radiotherapy | Experimental | A dose of 65 Gy is delivered to the primary tumor and affected lymph nodes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose escalated radiotherapy using a 1.5 T MR-Linac | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Two year TME-free survival | Patients alive and without TME-surgery | Two years from the start of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Clincal complete response rate | Patients who have no evidence of residual tumor on MRI and rectoscopy | three months after the end of radiotherapy |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cihan Gani, MD | Contact | +4970712982165 | cihan.gani@med.uni-tuebingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tübingen | Recruiting | Tübingen | Baden-Wurttemberg | 72074 | Germany |
Data will be shared if a sound scientific proposal if provided.
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |