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

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ClinicalTrials.gov Identifier: NCT03061058
Recruitment Status : Unknown
Verified September 2017 by Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Recruiting
First Posted : February 23, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stomach Neoplasms Chemotherapy Effect Chemotherapeutic Toxicity Drug: Docetaxel Drug: Oxaliplatin Drug: Cisplatin Drug: Irinotecan Drug: Pemetrexed Drug: S1 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase III, Multicenter Clinical Trial Comparing the Efficacy and Safety of Individualized Intraperitoneal and System Chemotherapy Versus System Chemotherapy as First-line Chemotherapy for Advanced Gastric Cancer
Actual Study Start Date : April 1, 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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).

Drug: Docetaxel
intraperitoneal and/or intravenous

Drug: Oxaliplatin
intravenous

Drug: Cisplatin
intraperitoneal

Drug: Irinotecan
intraperitoneal and/or intravenous

Drug: Pemetrexed
intraperitoneal and/or intravenous

Drug: S1
oral

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).

Drug: Docetaxel
intraperitoneal and/or intravenous

Drug: S1
oral




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to 1 year ]
    the follow-up visit of PFS will be performed every 6 weeks


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to 2 years ]
    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

  2. Objective Response Rate [ Time Frame: up to 24 weeks ]
    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

  3. Adverse Events [ Time Frame: up to 1 months ]
    participants will be followed for the duration of hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy.
  • 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:

  • Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; the total dose of cisplatin should be less than 300mg/m^2).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061058


Contacts
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Contact: Yang Yang, MD,PhD,MSCR 0086-18602568379 wing_young7@hotmail.com
Contact: Baorui Liu, MD, PhD 0086-13770621908 baoruiliu07@163.com

Locations
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China, Anhui
Ma'anshan People's Hospital Recruiting
Ma'anshan, Anhui, China
Contact: Fenglin Zhang, MD         
Contact: Fangbo Cui, MD         
China, Jiangsu
Jiangyin People's Hospital Recruiting
Jiangyin, Jiangsu, China
Contact: Weisheng Shen, MD         
Contact: Lei Xi, MD         
Nanjing Gaochun People's Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Rongfu Wei, MD         
Contact: Yajun Xin, MD         
Nanjing Lishui People's Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Chunlan Nie, MD         
Contact: Hui Xu, MD         
The Comprehensive Cancer Center of Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Yang Yang, MD,PhD,MSCR    0086-18602568379    wing_young7@hotmail.com   
Contact: Baorui Liu, MD, PhD    0086-13770621908    baoruiliu07@163.com   
Suqian People's Hospital Recruiting
Suqian, Jiangsu, China
Contact: Chuanwen You, MD         
Contact: Qing Zhu, MD         
Xuzhou Central Hospital Recruiting
Xuzhou, Jiangsu, China
Contact: Sanyuan Sun, MD         
Contact: Yuan Yuan, MD         
Affiliated Hospital of Jiangsu University Recruiting
Zhenjiang, Jiangsu, China
Contact: Xiaoqing Li, MD         
Contact: Meilian Cheng, MD         
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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Responsible Party: Yang Yang, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03061058    
Other Study ID Numbers: AGC-PC
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Docetaxel
Oxaliplatin
Irinotecan
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors