Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion Positive Locally Advanced Rectal Cancer
- Conditions
- Locally Advanced Rectal Cancer
- Interventions
- Drug: mFOLFOXIRI
- Registration Number
- NCT04170530
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- 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 mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.
- Detailed Description
It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) were enrolled in this trial. All EMVI+ LARC will receive the study regimen every 2 weeks for 6 cycles. MRI will be performed after 3 cycles of chemotherapy to assess clinical response.MRI was performed to assess clinical response after chemotherapy. Patients with mesorectal fascia-positive or ycT4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (TME).If the tumor response is good enough(partial response or complete response), the patient will receive another 3 cycles of FOLFOXIRI then surgery. On the contrary, if the tumor shows poor response(stable disease or progressive disease) or with mesorectal fascia-positive or ycT4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. All patients will receive 6 cycles of mFOLFOX6 or 4 cycles XELOX as adjuvant chemotherapy after TME.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 51
- Aged ≥ 18 to 75 years at diagnosis;
- ECOG status 0 or 1;
- Signed informed consent; able to comply with study and/or follow- up procedures;
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description mFOLFOXIRI mFOLFOXIRI patients received FOLFOXIRI alone for 6 cycles before surgery.
- Primary Outcome Measures
Name Time Method MFS Three years metastasis free survival
- Secondary Outcome Measures
Name Time Method Reported Adverse events 2 years The incidence of \>=3 grade adverse events
Tumor downstaging rate 2 years the proportion of tumor downstaging to ypT0-2N0M0
DFS 3 years disease-free survival
OS 5 years overall survival.
pCR 2 years Pathologic complete response rate
R0 rate 2 years R0 resection rate
locoregional recurrence 3 years The rate of local recurrence
Trial Locations
- Locations (1)
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China