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

Phase 2

Recruiting

• Conditions: Rectal Cancer
• Interventions: Radiation: Local dose increase of Short-course Radiotherapy; Radiation: Short-course Radiotherapy; Combination Product: Concurrent Chemoradiotherapy Radiotherapy; Drug: Adjuvant chemotherapy; Drug: Consolidation chemotherapy; Procedure: TME

• Registration Number: NCT04664504
• Lead Sponsor: Jing Jin, M.D.

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-06
• Last Update Posted: 2021-06-08
• Primary Completion: 2022-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group es-SCRT	TME	Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Group CRT	Adjuvant chemotherapy	concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
Group SCRT	TME	Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Group es-SCRT	Local dose increase of Short-course Radiotherapy	Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Group es-SCRT	Consolidation chemotherapy	Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Group CRT	TME	concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
Group SCRT	Short-course Radiotherapy	Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Group CRT	Concurrent Chemoradiotherapy Radiotherapy	concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
Group SCRT	Consolidation chemotherapy	Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
3yDMFS	3 years	3-year distant metastatic free survival
3y OS	3 years	3-year overall survival
3yLRRFS	3 years	3-year locoregional recurrence-free survival

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; 🇨🇳 Beijing, China