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

  • STATUS
    Recruiting
  • End date
    May 1, 2025
  • participants needed
    220
  • sponsor
    First Affiliated Hospital of Zhejiang University
Updated on 30 March 2021

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).

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 standard chemoradiotherapy. Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) are enrolled in this trial. All patients will be randomized divided into two groups.

Experimental group will receive 3 cycles of mFOLFOXIRI, followed to be performed MRI to assess clinical response. If the tumor response is good enough (partial response or complete response), the patient will receive another 3 cycles of mFOLFOXIRI 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. Control group will receive standard capecitabine based chemoradiotherapy.

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). All patients will receive 4 cycles of XELOX as adjuvant chemotherapy after TME.

Details
Condition Locally Advanced Rectal Cancer
Treatment Chemoradiotherapy, mFOLFOXIRI, mXELOXIRI
Clinical Study IdentifierNCT04423965
SponsorFirst Affiliated Hospital of Zhejiang University
Last Modified on30 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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