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

Jing Jin, M.D.

Status and phase: Enrolling; Phase 2

Conditions: Rectal Cancer

Treatments: Radiation: Short-course Radiotherapy; Drug: Consolidation chemotherapy; Drug: Adjuvant chemotherapy; Radiation: Local dose increase of Short-course Radiotherapy; Combination Product: Concurrent Chemoradiotherapy Radiotherapy; Procedure: TME

Study type: Interventional

Funder types: Other

Identifiers

NCT04664504

3332019055

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Group CRT

Active Comparator group

Description:

concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)

Treatment:

Combination Product: Concurrent Chemoradiotherapy Radiotherapy

Drug: Adjuvant chemotherapy

Procedure: TME

Group SCRT

Experimental group

Description:

Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)

Treatment:

Radiation: Short-course Radiotherapy

Procedure: TME

Drug: Consolidation chemotherapy

Group es-SCRT

Experimental group

Description:

Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)

Treatment:

Radiation: Local dose increase of Short-course Radiotherapy

Procedure: TME

Drug: Consolidation chemotherapy