Overview

A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC

Status:
Recruiting

Trial end date:
2025-05-01

Target enrollment:
0

Participant gender:
All

Summary

Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to the efficacy of standard Chemoradiotherapy (CRT).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

First Affiliated Hospital of Zhejiang University

Collaborators:

First Affiliated Hospital of Wenzhou Medical University
Zhejiang Cancer Hospital

Criteria

Inclusion Criteria:

1. Aged ≥ 18 to 70 years at diagnosis;

2. ECOG status 0-2;

3. Diagnosis of rectal adenocarcinoma(Distal border of the tumor must be located < 12 cm
from the anal verge);

4. MRI examination diagnosed EMVI-positive;

5. Tumor amenable to curative resection;

6. Adequate bone marrow, hepatic and renal function as assessed by the following
laboratory requirements conducted within 7 days of starting study treatment: (1)
Neutrophilic granulocytes ≥ 3.0 x10^9/L, Platelet count ≥ 75 x 10^9/L, Hemoglobin (Hb)
≥ 90g/L; (2) bilirubin ≤1.5 x the upper limit of normal (ULN),Alanine aminotransferase
(ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN; (3) Serum creatinine ≤ 1.5 x
ULN.No renal disease that would preclude study treatment or follow-up

7. Signed informed consent; able to comply with study and/or follow- up procedures

Exclusion Criteria:

1. Hypersensitivity to fluorouracil, oxaliplatin or irinotecan;

2. Patient had received pelvic radiotherapy;

3. Patient had received systemic chemotherapy;

4. History of invasive colon or rectal malignancy, regardless of disease-free interval;

5. Had metastatic disease;

6. Patient had second malignant disease within 5 years;

7. Uncontrolled co-morbid illnesses or other concurrent disease;

8. Patients refused to signed informed consent.

9. Pregnant and Nursing women