A Phase 3 interventional study of Docetaxel and Oxaliplatin in Stomach Neoplasms, Chemotherapy Effect and Chemotherapeutic Toxicity, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-15.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 3, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 240 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Drug: Docetaxel · Drug: Oxaliplatin · Drug: Cisplatin · Drug: Irinotecan · Drug: Pemetrexed · Drug: S1
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).
Drug: Docetaxel · Drug: S1
intraperitoneal and/or intravenous
intravenous
intraperitoneal
intraperitoneal and/or intravenous
intraperitoneal and/or intravenous
oral
Progression-free Survival (PFS)
the follow-up visit of PFS will be performed every 6 weeks
Time frame: up to 1 year
Overall Survival (OS)
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
Time frame: up to 2 years
Objective Response Rate
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
Time frame: up to 24 weeks
Adverse Events
participants will be followed for the duration of hospital stay
Time frame: up to 1 months
Plan to share: No
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School