Towards Response guided ADAptive Radiotherapy for organ preserving treatment of intermediate risk rectal cancer: a phase I dose finding trial
- Conditions
- rectal cancer
- Registration Number
- NL-OMON22916
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
Age =18;
- Biopsy proven rectal adenocarcinoma;
- Intermediate risk tumor, based on TNM (AJCC 8th edition) stage (T3c-d (MRF-) N0M0 or cT1-3 (MRF-) N1M0)
- Mid-rectal or distal rectal tumor: lower border anteriorly not above peritoneal fold, upper border below sigmoid take-off;
- Indication for neoadjuvant short course radiotherapy as judged by multidisciplinary tumor board discussion;
- Fit for multimodal treatment, as judged by multidisciplinary tumor board discussion;
- Written informed consent.
- Mucinous tumor or neuro-endocrine tumor, as defined on MRI and/or histopathology;
- No residual luminal tumor after local excision;
- Recurrent tumor or regrowth after previous treatment;
- Extra-mesorectal pathological lymph nodes;
- Planned systemic therapy (either with curative or palliative intent);
- History of inflammatory bowel disease;
- Prior pelvic radiotherapy;
- Contraindications for MRI at 1.5T;
- Orthopedic hip implants;
- Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method