Individualized Intraperitoneal and System Chemotherapy Versus System Chemotherapy as First-line Chemotherapy for AGC
NCT ID: NCT03061058
Last Updated: 2017-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
240 participants
INTERVENTIONAL
2013-04-01
2019-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
Docetaxel
intraperitoneal and/or intravenous
Oxaliplatin
intravenous
Cisplatin
intraperitoneal
Irinotecan
intraperitoneal and/or intravenous
Pemetrexed
intraperitoneal and/or intravenous
S1
oral
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).
Docetaxel
intraperitoneal and/or intravenous
S1
oral
Interventions
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Docetaxel
intraperitoneal and/or intravenous
Oxaliplatin
intravenous
Cisplatin
intraperitoneal
Irinotecan
intraperitoneal and/or intravenous
Pemetrexed
intraperitoneal and/or intravenous
S1
oral
Eligibility Criteria
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Inclusion Criteria
* Patients must have measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1), assessed using imaging techniques (CT or MRI).
* Patients must have enough tumor tissue for mRNA expression test.
* Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to chemotherapy, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 6 months after therapy completed
* Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1 or 2.
* Absolute neutrophil count (ANC) \>=1,500/ul
* Platelets (PLT) \>=75,000/ul
* Serum bilirubin \<= 1.5 × upper limit of normal (ULN)
* Aspartate transaminase (AST) or alanine aminotransferase (ALT) \<= 2.5 × ULN (or \<= 5 × ULN in patients with liver metastases)
* Alkaline phosphatase \<= 2.5 × ULN (or \<= 5 × ULN in patients with liver metastases, or \<= 10 × ULN in patients with bone but no liver metastases)
* Albumin \>= 25 g/L.
* Creatinine clearance \>= 60 mL/min.
* Life expectancy of at least 3 months.
* Signed informed consent.
Exclusion Criteria
* Patients with active (significant or uncontrolled) gastrointestinal bleeding.
* Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE 4.0.
* Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
* History of documented congestive heart failure; angina pectoris requiring medication;evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
* Baseline left ventricular ejection fraction (LVEF) \< 50% (measured by echocardiography or MUGA).
* Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
* Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
* Clinically significant hearing abnormality.
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
* History or clinical evidence of brain metastases.
* Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
* Positive serum pregnancy test in women of childbearing potential.
* Received any investigational drug treatment within 4 weeks of start of study treatment.
* Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recovered from any acute toxicity;prior adjuvant radiotherapy is allowed if complete at least 6 months ).
* Major surgery within 4 weeks of start of study treatment, without complete recovery.
* Patients with known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
* Known hypersensitivity to any of the study drugs.
18 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Yang Yang
Principal investigator
Locations
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Ma'anshan People's Hospital
Ma’anshan, Anhui, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, China
Nanjing Gaochun People's Hospital
Nanjing, Jiangsu, China
Nanjing Lishui People's Hospital
Nanjing, Jiangsu, China
The Comprehensive Cancer Center of Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Suqian People's Hospital
Suqian, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Fenglin Zhang, MD
Role: primary
Fangbo Cui, MD
Role: backup
Weisheng Shen, MD
Role: primary
Lei Xi, MD
Role: backup
Rongfu Wei, MD
Role: primary
Yajun Xin, MD
Role: backup
Chunlan Nie, MD
Role: primary
Hui Xu, MD
Role: backup
Chuanwen You, MD
Role: primary
Qing Zhu, MD
Role: backup
Sanyuan Sun, MD
Role: primary
Yuan Yuan, MD
Role: backup
Xiaoqing Li, MD
Role: primary
Meilian Cheng, MD
Role: backup
Other Identifiers
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AGC-PC
Identifier Type: -
Identifier Source: org_study_id