A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Overview
- Phase
- Phase 2
- Intervention
- Concurrent Chemoradiotherapy Radiotherapy
- Conditions
- Rectal Cancer
- Sponsor
- Jing Jin, M.D.
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- R0 resection rate
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Jing Jin, M.D.
Clinical Professor, Radiotherapy Department
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Rectal adenocarcinoma confirmed by histopathology
- •MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
- •The age is 18-75 years old, no gender limit
- •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
- •History of other malignant tumors;
- •They were allergic to 5-FU, platinum, etc;
- •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;
- •After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
- •History of gastrointestinal fistula, perforation or severe ulcer;
- •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.
Arms & Interventions
Group CRT
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
Intervention: Concurrent Chemoradiotherapy Radiotherapy
Group CRT
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
Intervention: Adjuvant chemotherapy
Group CRT
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
Intervention: TME
Group SCRT
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Intervention: Short-course Radiotherapy
Group SCRT
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Intervention: Consolidation chemotherapy
Group SCRT
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Intervention: TME
Group es-SCRT
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Intervention: Local dose increase of Short-course Radiotherapy
Group es-SCRT
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Intervention: Consolidation chemotherapy
Group es-SCRT
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Intervention: TME
Outcomes
Primary Outcomes
R0 resection rate
Time Frame: 1 year
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy
Secondary Outcomes
- 3yDMFS(3 years)
- 3yLRRFS(3 years)
- 3y OS(3 years)