A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Study Overview
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Brief Summary
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A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Detailed Description
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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.

Official Title
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A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Conditions
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Rectal Cancer

Intervention / Treatment
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* Combination Product: Concurrent Chemoradiotherapy Radiotherapy
* Radiation: Short-course Radiotherapy
* Radiation: Local dose increase of Short-course Radiotherapy
* Drug: Consolidation chemotherapy
* Drug: Adjuvant chemotherapy
* Procedure: TME


Participation Criteria
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Eligibility Criteria
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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 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group CRT<br>concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group) | Combination Product: Concurrent Chemoradiotherapy Radiotherapy<br>* 50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.<br>* Other names: CRT;Drug: Adjuvant chemotherapy<br>* 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<br>* Other names: XEOLX*6 courses;Procedure: TME<br>* Total mesorectal excision<br>|
| Experimental: Group SCRT<br>Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group) | Radiation: Short-course Radiotherapy<br>* 25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.<br>* Other names: SCRT;Drug: Consolidation chemotherapy<br>* 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.<br>* Other names: XEOLX*4 courses;Procedure: TME<br>* Total mesorectal excision<br>|
| Experimental: Group es-SCRT<br>Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group) | Radiation: Local dose increase of Short-course Radiotherapy<br>* 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.<br>* Other names: es-SCRT;Drug: Consolidation chemotherapy<br>* 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.<br>* Other names: XEOLX*4 courses;Procedure: TME<br>* Total mesorectal excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate | R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3y OS | 3-year overall survival | 3 years | 
| 3yDMFS | 3-year distant metastatic free survival | 3 years | 
| 3yLRRFS | 3-year locoregional recurrence-free survival | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Cancer, Neoadjuvant Chemoradiotherapy, Recurrence Risk