Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for mCRC

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT03792269
Phase
PHASE2
Status
Unknown

Conditions

  • Chemotherapeutic Toxicity
  • Chemotherapy Effect
  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    intraperitoneal
  • Oxaliplatin — DRUG
    intravenous
  • Capecitabine — DRUG

Study Details

XELOX as first-line treatment regimen has limited efficacy against patients with metastatic colorectal cancer (mCRC). Peritoneal metastasis is one of the most lethal factor for mCRC. Intraperitoneal chemotherapy has became a widely accepted strategy in the treatment of peritoneal dissemination. We hypothesized that combined multi-channel administration, such as intraperitoneal chemotherapy, oral chemotherapy, and intravenous chemotherapy, can produce better results than XELOX for first-line treatment for mCRC patients.

Key Dates

Start date
Jan 1, 2016
Status verified
Jan 2019
Primary completion
Dec 31, 2019
Completion
Dec 31, 2020

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Multi-channel chemotherapy
    Patients will receive intraperitoneal irinotecan (50mg, d1, q2w).
  • Active Comparator: Control Group
    Patients will receive intravenous oxaliplatin (130mg/m\^2, d1, q3w), and oral capecitabine (1.0g, d1-14, q3w).

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: up to 1 year ]

Central Contacts

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