Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 11, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date September 15, 2017
Actual Study Start Date  ICMJE April 1, 2013
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
Progression-free Survival (PFS) [ Time Frame: up to 1 year ]
the follow-up visit of PFS will be performed every 6 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
  • 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
  • Objective Response Rate [ Time Frame: up to 24 weeks ]
    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
  • Adverse Events [ Time Frame: up to 1 months ]
    participants will be followed for the duration of hospital stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Intraperitoneal and System Chemotherapy Versus System Chemotherapy as First-line Chemotherapy for AGC
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Stomach Neoplasms
  • Chemotherapy Effect
  • Chemotherapeutic Toxicity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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).

    Interventions:
    • Drug: Docetaxel
    • Drug: Oxaliplatin
    • Drug: Cisplatin
    • Drug: Irinotecan
    • Drug: Pemetrexed
    • Drug: S1
  • 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).

    Interventions:
    • Drug: Docetaxel
    • Drug: S1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 13, 2017)
240
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2017)
120
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03061058
Other Study ID Numbers  ICMJE AGC-PC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sponsor  ICMJE The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP