Randomized Multicentre Phase III study of short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in primary high risk rectal cancer compared to standard chemoradiotherapy and surgery and optional adjuvant chemotherapy (RAPIDO study)
- Conditions
- rectal cancer10017990
- Registration Number
- NL-OMON47895
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 361
• Biopsy-proven, newly diagnosed primary rectal adenocarcinoma.
• Locally advanced tumour fulfilling at least one of the following criteria on
pelvic MRI indicating high risk of failing locally and/or systemically:
o Clinical stage (c) T4a
o cT4b
o EMVI+
o N2
o Positive MRF, i.e. tumour <= 1 mm from the mesorectal fascia
• Staging done within 5 weeks before randomization.
• Age >= 18 years.
• ECOG Performance Status of 0 - 1.
• Extensive growth into cranial part of the sacrum (above S3) or the
lumbosacral nerve roots.
• Metastatic disease or recurrent rectal tumour. Familial Adenomatosis
Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC),
active Crohn*s disease or active ulcerative Colitis.
• Pregnancy or lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>disease related treatment failure.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival, CRM negative (margin > 1 mm) rate, Pathological complete<br /><br>response (pCR) rate, Short and long-term toxicity, Surgical complications,<br /><br>Quality of life. Pharmacogenomics.</p><br>