A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC
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- STATUS
- Recruiting
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- End date
- May 1, 2025
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- participants needed
- 220
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- sponsor
- First Affiliated Hospital of Zhejiang University
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 Identifier | NCT04423965 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Last Modified on | 30 March 2021 |
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