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

Sponsor
West China Hospital
Study ID
NCT05018182
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m² Q2w(2 h) before surgery rection and 130 mg/m² Q3w (2 h) after surgery
  • Irinotecan — DRUG
    Irinotecan 150 mg/m² ivgtt(1.5 h) Q2w before surgery rection
  • Folinic Acid — DRUG
    Folinic acid 400 mg/m² ivgtt(2 h) Q2w before surgery rection
  • 5FU — DRUG
    5-FU 2800 mg/m² civ(46 h) Q2w before surgery rection
  • Capecitabine — DRUG
    Capecitabine 1000mg/m² d1-14 po Q3w after surgery rection

Study Details

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.

Key Dates

Start date
Aug 2, 2021
Status verified
Aug 2021
Primary completion
Apr 30, 2022
Completion
Aug 2, 2022

Study Design

Enrollment
69 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemotherapy
    4 cycles of neoadjuvant chemotherapy with FOLFOXIRI + operation + 5 cycles of adjuvant chemotherapy with XELOX

Primary Outcome Measure

Pathological response [ Time Frame: up to 24 weeks ]

Central Contacts

Related Studies