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

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

Recruiting
18-70 years
All
Phase 2

It is an investigator-initiated, multicentered, randomized controlled clinical study to evaluate the efficacy and safety of mXELOXIRI 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 mXELOXIRI, 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 mXELOXIRI 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.

Study details
    Locally Advanced Rectal Cancer

NCT04423965

First Affiliated Hospital of Zhejiang University

19 February 2024

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