Intraperitoneal Aerosol Chemotherapy in Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A prospective series of patients with recurrent gastric cancer will be treated with three
      cycles of chemotherapy (doxorubicin and cisplatin) instilled into the abdominal cavity in the
      form of an aerosol under pressure via laparoscopy. The efficacy of this treatment will be
      assessed by computed tomography, tumor marker studies, and survival. Also, the safety of the
      procedure will be assessed.
    

Detailed description: 
      Objectives: To evaluate the safety and efficacy in terms of the clinical benefit rate (CBR)
      of PIPAC in peritoneal carcinomatosis (PC) from gastric cancer (GC) Study design: Single
      center, open label, non-randomized, single-arm, repeated single dose study to explore the
      efficacy, safety, and CBR of doxorubicin and cisplatin when given as a pressurized
      intraperitoneal aerosol chemotherapy (PIPAC) to patients with advanced gastric cancer and
      peritoneal carcinomatosis.

      Target subject population:Patients with GC and PC with disease progression after at least one
      line of previous i.v. chemotherapy.

      Investigational product, dosage and mode of administration Doxorubicin 1.5 mg/m2 body surface
      in 50 ml NaCl 0,9% and Cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4-6 weeks, applied
      intraperitoneally as PIPAC.

      Duration of treatment: 3 single doses in 6 weeks intervals, duration of treatment is 18 weeks

      Outcome variables:

      1.1 Primary outcome variable • Clinical Benefit Rate (CBR) according to Response Evaluation
      Criteria In Solid Tumors (RECIST) criteria (version 1.1) after 3 cycles of PIPAC with
      cisplatin and doxorubicin.

      1.2 Secondary outcome variables

        -  The observed survival (OS)

        -  The median time to progression (TTP) according to RECIST criteria after three cycles of
           PIPAC with cisplatin and doxorubicin

        -  The Peritoneal Carcinomatosis Index (PCI) before and after therapy

        -  The degree of histological regression assessed by pathological review

        -  Apoptosis as assessed by immunohistochemical analysis

        -  The difference in ascites volume before and after the first, second, and third PIPAC
           application 1.3 Patient reported outcomes (PROs)

        -  European Organization for Research and Treatment of Cancer (EORTC) quality of life
           questionnaire (QLQ-C30, German version ) 1.4 Safety

        -  Safety and tolerability will be assessed by collection of adverse events, according to
           the Common Terminology Criteria for Adverse Events (CTCAE) including physical
           examination results, laboratory assessments (chemistry and hematology).

      1.5 Biological monitoring

      • Basic research investigating expression of genes associated with drug resistance.
    

Intervention name(s): doxorubicin and cisplatin
Intervention type(s): Drug
Intervention description(s): doxorubicin and cisplatin as intraperitoneal chemotherapy
Other intervention name(s): doxorubicin 50 HEXAL®; cisplatin 10 HEXAL®
Intervention MeSH terms: Cisplatin; Doxorubicin; Liposomal doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric; Cancer; Chemotherapy; Intraperitoneal