Status:
UNKNOWN
A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
First Affiliated Hospital of Wenzhou Medical University
Zhejiang Cancer Hospital
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 FOLFOXIR...
Detailed Description
It is an investigator-initiated, multicentered, randomized controlled clinical study to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to s...
Eligibility Criteria
Inclusion
- Aged ≥ 18 to 70 years at diagnosis;
- ECOG status 0-2;
- Diagnosis of rectal adenocarcinoma(Distal border of the tumor must be located \< 12 cm from the anal verge);
- MRI examination diagnosed EMVI-positive;
- Tumor amenable to curative resection;
- 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
- Signed informed consent; able to comply with study and/or follow- up procedures
Exclusion
- Hypersensitivity to fluorouracil, oxaliplatin or irinotecan;
- Patient had received pelvic radiotherapy;
- Patient had received systemic chemotherapy;
- History of invasive colon or rectal malignancy, regardless of disease-free interval;
- Had metastatic disease;
- Patient had second malignant disease within 5 years;
- Uncontrolled co-morbid illnesses or other concurrent disease;
- Patients refused to signed informed consent.
- Pregnant and Nursing women
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04423965
Start Date
May 12 2020
End Date
May 1 2025
Last Update
March 23 2021
Active Locations (1)
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1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006