Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion Positive Locally Advanced Rectal Cancer

• Status: Recruiting
• Trial end date: 2022-01-01
• 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 mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Treatments: Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

1. Aged ≥ 18 to 75 years at diagnosis;

2. ECOG status 0 or 1;

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

4. Diagnosis of rectal adenocarcinoma;

5. Distal border of the tumor must be located < 12 cm from the anal verge;

6. MRI examination diagnosed EMVI-positive;

7. Tumor amenable to curative resection;

8. 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.

9. No renal disease that would preclude study treatment or follow-up

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;