OPtimizing Preoperative EndoRectal BrachyTherapy (OPPER-BT)
- Conditions
- adenocarcinoma of the rectumRectal cancerrectal tumor1001799010017991
- Registration Number
- NL-OMON45506
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
* Adenocarcinoma of the rectum
* Clinically T1-2N1 or T3N0 with > 5 mm extramural invasion or T3N1 tumor
* No threatened or involved mesorectal fascia on MRI
* Eligible for 5x5 Gy according to the Dutch guidelines
* Cranial edge of the tumor below sigmoid curvature on MRI
* Caudal margin of the tumor above dentate line (endoscopic observation)
* Tumors with an adequate (>2 cm) lumen to allow the positioning of the applicator (e.g. non obstructive tumor)
* WHO performance status 0-2 (Appendix B)
* Age > 18 years
* Extramesorectal (e.g. iliac, lateral) pelvic lymph node involvement
* Previous pelvic irradiation
* Extension of tumor into the anal canal
* Contra-indication for endoscopic placement of gold-markers such as coagulopathy (prothrombin time < 50% of control; partial thromboplastin time > 50 seconds) or anticoagulantia (marcoumar, sintrom or new oral anticoagulants) that cannot be stopped.
* Contra-indications for a MRI exam with Gadolinium according to the institutional policy
* Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method