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Status unknownNCT03061058Updated Sep 15, 2017

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

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

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Apr 2013, registered Feb 2017).
Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stomach Neoplasms
  • Chemotherapy Effect
  • Chemotherapeutic Toxicity

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03

In context

Stomach Neoplasms

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
240 participants (estimated)

Study arms

  • 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 · 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).

    Drug: Docetaxel · Drug: S1

Interventions

  • DrugDocetaxel

    intraperitoneal and/or intravenous

  • DrugOxaliplatin

    intravenous

  • DrugCisplatin

    intraperitoneal

  • DrugIrinotecan

    intraperitoneal and/or intravenous

  • DrugPemetrexed

    intraperitoneal and/or intravenous

  • DrugS1

    oral

06

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS)

    the follow-up visit of PFS will be performed every 6 weeks

    Time frame: up to 1 year

Secondary outcomes

  1. 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

  2. Objective Response Rate

    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

    Time frame: up to 24 weeks

  3. Adverse Events

    participants will be followed for the duration of hospital stay

    Time frame: up to 1 months

07

Study locations

8 of 8 sites recruiting
  • Ma'anshan People's Hospital
    Ma'anshan, Anhui, China
    • Fenglin Zhang, MD · Contact
    • Fangbo Cui, MD · Contact
    Recruiting
  • Jiangyin People's Hospital
    Jiangyin, Jiangsu, China
    • Weisheng Shen, MD · Contact
    • Lei Xi, MD · Contact
    Recruiting
  • Nanjing Gaochun People's Hospital
    Nanjing, Jiangsu 210000, China
    • Rongfu Wei, MD · Contact
    • Yajun Xin, MD · Contact
    Recruiting
  • Nanjing Lishui People's Hospital
    Nanjing, Jiangsu 210000, China
    • Chunlan Nie, MD · Contact
    • Hui Xu, MD · Contact
    Recruiting
  • The Comprehensive Cancer Center of Nanjing Drum Tower Hospital
    Nanjing, Jiangsu 210008, China
    Recruiting
  • Suqian People's Hospital
    Suqian, Jiangsu, China
    • Chuanwen You, MD · Contact
    • Qing Zhu, MD · Contact
    Recruiting
  • Xuzhou Central Hospital
    Xuzhou, Jiangsu, China
    • Sanyuan Sun, MD · Contact
    • Yuan Yuan, MD · Contact
    Recruiting
  • Affiliated Hospital of Jiangsu University
    Zhenjiang, Jiangsu, China
    • Xiaoqing Li, MD · Contact
    • Meilian Cheng, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03061058
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Yang Yang (Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Feb 23, 2017
Start date
Apr 1, 2013
Primary completion
Dec 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Sep 15, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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