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

NCT04423965 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-03-23

No results posted yet for this study

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).

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

mFOLFOXIRI

irinotecan 165 mg/m² IV day 1+ oxaliplatin 85 mg/m² IV day 1 + leucovorin 400 mg/m² day 1, fluorouracil 1200mg/m²/day \*2 days (total 2400 mg/m² over 48 hours) continuous infusion starting on day 1 of each 2 weeks cycle

COMBINATION_PRODUCT

Chemoradiotherapy

Capecitabine based chemoradiotherapy

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-12
Primary Completion
2022-05-01
Completion
2025-05-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04423965 on ClinicalTrials.gov