Individualized Intraperitoneal and System Chemotherapy Versus System Chemotherapy as First-line Chemotherapy for AGC

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT03061058
Phase
PHASE3
Status
Unknown

Conditions

  • Chemotherapeutic Toxicity
  • Chemotherapy Effect
  • Stomach Neoplasms

Eligibility Criteria

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

Interventions

  • Docetaxel — DRUG
    intraperitoneal and/or intravenous
  • Oxaliplatin — DRUG
    intravenous
  • Cisplatin — DRUG
    intraperitoneal
  • Irinotecan — DRUG
    intraperitoneal and/or intravenous
  • Pemetrexed — DRUG
    intraperitoneal and/or intravenous
  • S1 — DRUG
    oral

Study Details

Tumor messenger ribonucleic acid (mRNA) expression levels may have a promising role as potential predictive biomarkers for chemotherapy. Peritoneal carcinomatosis appears to be the most common pattern of metastasis or recurrence and is associated with poor prognosis in gastric cancer patients. Intraperitoneal chemotherapy is widely accepted strategy in the treatment of peritoneal dissemination. In this study, our aim is to evaluate the impact of individualized selection of chemotherapeutics and intraperitoneal combined with system chemotherapy on overall survival, disease free survival, response rate, and safety of advanced gastric cancer patients.

Key Dates

Start date
Apr 1, 2013
Status verified
Sep 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019

Study Design

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

Arms

  • Experimental: Individualized Group
    mRNA levels of BRCA1, topoisomerase I (TOPO1), and thymidylate synthase (TS) were assessed in tumor tissue. Chemotherapeutic agents were selected based on the mRNA levels. Patients with high level BRCA1 will receive intraperitoneal docetaxel (15mg/m\^2, d1, d15, q4w), intravenous docetaxel (30mg/m\^2, d1, d15, q4w), and oral S-1 (40mg/m\^2, d1-14, q4w). Patients with low level BRCA1 will receive intraperitoneal cisplatin (25mg/m\^2, d1, d15, q4w), intravenous oxaliplatin (75mg/m\^2, d1, d15, q4w), and oral S-1 (40mg/m\^2, d1-14, q4w). Patients with middle level BRCA1 and high level TOPO1 will receive intraperitoneal irinotecan (45mg/m\^2, d1, d15, q4w), intravenous docetaxel (90mg/m\^2, d1, d15, q4w), and oral S-1 (40mg/m\^2, d1-14, q4w). Patients with middle level BRCA1, low or middle level TOPO1, and low level TS will receive intraperitoneal pemetrexed (150mg/m\^2, d1, q3w), and intravenous pemetrexed (350mg/m\^2, d1, q3w).
  • Active Comparator: Control Group
    mRNA levels of BRCA1, TOPO1, and TS were assessed in tumor tissue for every enrolled patients. Patients in control group will receive intravenous docetaxel (45mg/m\^2, d1, d15, q4w), and oral S-1 (40mg/m\^2, d1-14, q4w).

Primary Outcome Measure

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

Central Contacts

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