Randomized multicentre phase III study of short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in patients with high risk primary rectal cancer compared to standard preoperative chemoradiotherapy, surgery and optional adjuvant chemotherapy.
Completed
- Conditions
- Primary rectal cancer with high risk of failing locally and/or systemically.Keywords: rectal cancer, neoadjuvant chemotherapy, short course radiotherapy
- Registration Number
- NL-OMON24092
- Lead Sponsor
- niversity Medical Center Groningen, PO BOX 3001 , 9700 RB , Groningen , The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 885
Inclusion Criteria
Primary tumour characteristics:
1. Histological proof of newly diagnosed primary adenocarcinoma of the rectum;
Exclusion Criteria
1. Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen;
2. Presence of metastatic disease or recurrent rectal tumour;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease related Treatment Failure (3-years after surgery)
- Secondary Outcome Measures
Name Time Method 1. Overall survival;<br /><br>2. CRM negative (margin > 1 mm) rate;<br /><br>3. Pathological complete response (pCR) rate;<br /><br>4. Short and long-term toxicity;<br /><br>5. Surgical complications;<br /><br>6. Quality of life.