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

STATUS

Recruiting
End date

May 1, 2025
participants needed

220
sponsor

First Affiliated Hospital of Zhejiang University

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Updated on 19 February 2024

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cancer

platelet count

renal function

metastasis

adenocarcinoma

chemoradiotherapy

rectal carcinoma

adenocarcinoma of rectum

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 XELOXIRI 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 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.

Details

Condition	Locally Advanced Rectal Cancer
Age	18years - 70years
Treatment	mXELOXIRI, Chemoradiotherapy
Clinical Study Identifier	NCT04423965
Sponsor	First Affiliated Hospital of Zhejiang University
Last Modified on	19 February 2024

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