Actively Recruiting
MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-05-29
200
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Improvements in downstaging are required when using preoperative chemoradiation for unresectable rectal cancer. There is therefore a need to explore more effective schedules. The study arm will receive MRI simulation-guided boost in short-course preoperative radiotherapy followed by consolidation chemotherapy , which may enhance the shrinkage of tumor comparing with the concurrent chemoradiation.
CONDITIONS
Official Title
MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven rectal adenocarcinoma
- Tumor located within 10 cm of the anal verge
- Locally advanced tumor (T3, T4, or lymph node positive) based on AJCC Cancer Staging
- Positive mesorectal fascia or T4b evaluated by pelvic MRI
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Written informed consent provided
- Mentally and physically able to receive chemotherapy
- Adequate blood counts and organ function: white blood cell count 3.5 x 10^9/L, hemoglobin 100 g/L, platelet count 100 x 10^9/L, creatinine, urea nitrogen, ALT, AST, ALP, and total bilirubin 1.5 times upper normal limit
- No prior tumor excision, chemotherapy, or anti-tumor treatment after diagnosis
You will not qualify if you...
- Presence of distant metastases
- Recurrent rectal cancer
- Active Crohn's disease or ulcerative colitis
- Other simultaneous cancers except basal cell carcinoma or in-situ cervical carcinoma
- Allergy to fluorouracil or platinum drugs
- Contraindications to MRI
- Uncontrolled medical conditions
- Pregnancy or breastfeeding
- Known malabsorption syndromes or physical impairment of upper gastrointestinal tract
- Symptoms or history of peripheral neuropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, China, 100021
Actively Recruiting
Research Team
J
Jing Jin, M.D.
CONTACT
W
Wen-Yang Liu, M.D.
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