Actively Recruiting
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
Led by Larissa University Hospital · Updated on 2024-10-08
84
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.
CONDITIONS
Official Title
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed rectal adenocarcinoma
- Clinical stage cT3 or cT4, threatened circumferential resection margin or mesorectal fascia, EMVI positive, or N1 or higher
- Multidisciplinary tumor board decision for neoadjuvant treatment
- Tumor located less than 15 cm from the anal verge by endoscopy or MRI
- Age between 18 and 80 years
- General health status WHO 0-1
- No co-morbidities affecting treatment
- Neutrophils above 1,500/mm3, platelets above 100,000/mm3, hemoglobin above 10 g/dL
- Normal creatinine and creatinine clearance above 50 mL/min
- Signed informed consent
You will not qualify if you...
- Presence of distant metastases
- Non-resectable cancer
- Contraindications to chemotherapy
- Previous pelvic radiotherapy or chemotherapy
- History of inflammatory bowel disorders
- History of angina, acute myocardial infarction, or heart failure
- Active sepsis or systemic infection
- Untreated physical or mental disability
- Synchronous malignancy
- Pregnancy or breastfeeding
- Lack of compliance with study protocol
- Not signing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Surgery, University Hospital of Larissa
Larissa, Greece, 41110
Actively Recruiting
Research Team
K
Konstantinos Perivoliotis, MD
CONTACT
G
George Tzovaras, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here