MedTrace Logo

FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer

NCT05018182 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-08-24

No results posted yet for this study

Summary

The main cause of recurrence after surgical treatment of colorectal cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. The FOLFOXIRI regimen has been shown to have a high objective efficiency in advanced colorectal cancer. This phase II trial is to explore the pathological remission rate and safety of stage II/III locally advanced colon cancer with high risk of recurrence to FOLFOXIRI regimen of neoadjuvant chemotherapy alone.

Conditions

  • High-risk Locally Advanced Colorectal Cancer
  • Neoadjuvant Chemotherapy
  • FOLFOXIRI Regimen

Interventions

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m² Q2w(2 h) before surgery rection and 130 mg/m² Q3w (2 h) after surgery

DRUG

Irinotecan

Irinotecan 150 mg/m² ivgtt(1.5 h) Q2w before surgery rection

DRUG

Folinic Acid

Folinic acid 400 mg/m² ivgtt(2 h) Q2w before surgery rection

DRUG

5FU

5-FU 2800 mg/m² civ(46 h) Q2w before surgery rection

DRUG

Capecitabine

Capecitabine 1000mg/m² d1-14 po Q3w after surgery rection

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Weibing Leng, Ph.D · Sichuan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2022-04-30
Completion
2022-08-02

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05018182 on ClinicalTrials.gov