Rectal Cancer
Conditions
Keywords
Rectal Cancer, Neoadjuvant Chemoradiotherapy, Recurrence Risk
Brief summary
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Detailed description
For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.
Interventions
COMBINATION_PRODUCTConcurrent Chemoradiotherapy Radiotherapy
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.
RADIATIONShort-course Radiotherapy
25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
RADIATIONLocal dose increase of Short-course Radiotherapy
25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses\*3 weeks per course.
DRUGAdjuvant chemotherapy
2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses\*3 weeks per course
PROCEDURETME
Total mesorectal excision
Sponsors
Jing Jin, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Rectal adenocarcinoma confirmed by histopathology 2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+) 3. The age is 18-75 years old, no gender limit 3\) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1
Exclusion criteria
1. History of other malignant tumors; 2. They were allergic to 5-FU, platinum, etc; 3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred; 4. After the previous renal history, proteinuria or clinical renal function were found to be abnormal; 5. History of gastrointestinal fistula, perforation or severe ulcer; 6. At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 1 year | R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3y OS | 3 years | 3-year overall survival |
| 3yDMFS | 3 years | 3-year distant metastatic free survival |
| 3yLRRFS | 3 years | 3-year locoregional recurrence-free survival |
Countries
China
Contacts
Primary ContactYuan Tang, M.D.
Outcome results
None listed