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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Group | Experimental | 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). |
|
| Control Group | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | intraperitoneal and/or intravenous |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | the follow-up visit of PFS will be performed every 6 weeks | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 2 years |
| Objective Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Yang, MD,PhD,MSCR | Contact | 0086-18602568379 | wing_young7@hotmail.com | |
| Baorui Liu, MD, PhD | Contact | 0086-13770621908 | baoruiliu07@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ma'anshan People's Hospital | Recruiting | Ma’anshan | Anhui | China |
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| Oxaliplatin |
| Drug |
intravenous |
|
| Cisplatin | Drug | intraperitoneal |
|
| Irinotecan | Drug | intraperitoneal and/or intravenous |
|
| Pemetrexed | Drug | intraperitoneal and/or intravenous |
|
| S1 | Drug | oral |
|
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
| up to 24 weeks |
| Adverse Events | participants will be followed for the duration of hospital stay | up to 1 months |
| Jiangyin People's Hospital | Recruiting | Jiangyin | Jiangsu | China |
|
| Nanjing Gaochun People's Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Nanjing Lishui People's Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| The Comprehensive Cancer Center of Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
|
| Suqian People's Hospital | Recruiting | Suqian | Jiangsu | China |
|
| Xuzhou Central Hospital | Recruiting | Xuzhou | Jiangsu | China |
|
| Affiliated Hospital of Jiangsu University | Recruiting | Zhenjiang | Jiangsu | China |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000077150 | Oxaliplatin |
| D002945 | Cisplatin |
| D000077146 | Irinotecan |
| D000068437 | Pemetrexed |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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