Intraperitoneal Aerosol Chemotherapy in Gastric Cancer

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: doxorubicin and cisplatin

• Registration Number: NCT01854255
• Lead Sponsor: Ruhr University of Bochum

Brief 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.

Study Timeline

• Study First Submitted: 2013-05-12
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-15
• Study Start: 2013-11
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• age above 18 years
• written, informed consent
• presence of peritoneal carcinomatosis

Exclusion Criteria

• language barrier
• parenchymal metastases
• unability to undergo laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraperitoneal Chemotherapy	doxorubicin and cisplatin	Patients will receive 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 pressurized aerosol chemotherapy. Duration of treatment will be 3 single doses in 6 weeks intervals, thus the duration of treatment is 18 weeks.

Primary Outcome Measures

Name	Time	Method
Clinical Benefit Rate	within 3 months after treatment completion	Clinical Benefit Rate according to RECIST criteria after 3 cycles of PIPAC with cisplatin and doxorubicin.

Secondary Outcome Measures

Name	Time	Method
Observed Survival	During treatment and follow-up of 1 year	Survival will be assessed by direct observation during treatment and by follow-up investigation for 1 year after completion of the study

Trial Locations

Locations (1)

Ruhr University of Bochum; 🇩🇪 Herne, North Rhine Westphalia, Germany