NCT05318794

Brief Summary

Data demonstrating the efficacy of PIPAC in patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease is limited due to the relatively recent development of this technique and its historical preferential use in palliative patients with disseminated peritoneal metastasis. Existing data suggest PIPAC administered every six weeks in conjunction with standard treatment may work as an adjunct to conventional systemic neoadjuvant chemotherapy. PIPAC protocols have been established both for gastric cancer as well as other intra-abdominal malignancies and have a good safety profile. Given these promising findings, a study protocol is proposed herein to further investigate PIPAC for the treatment of a highly selected group of patients with regionally advanced gastric cancer (positive peritoneal cytology and/or minimal peritoneal disease).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 gastric-cancer

Timeline
50mo left

Started Nov 2023

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Nov 2023Jul 2030

First Submitted

Initial submission to the registry

March 17, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Expected
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

March 17, 2022

Last Update Submit

September 12, 2023

Conditions

Gastric CancerPeritoneal MetastasesChemotherapy Effect

Keywords

Pressurised intraperitoneal aerosol chemotherapyPIPACNeoadjuvant therapyGastrectomyCurativeDoxorubicinCisplatin

Outcome Measures

Primary Outcomes (1)

  • Feasibility and safety of combined neoadjuvant systemic chemotherapy and pressurised intraperitoneal aerosol chemotherapy (PIPAC)

    Barrier and mitigating factors or the provision of combined neoadjuvant systemic chemotherapy and PIPAC will be assessed. Safety of this intervention in terms of risks to patients and staff will also be evaluated.

    2 years

Secondary Outcomes (4)

  • Tumour regression

    2 years

  • Patient morbidity

    2 years

  • Health related quality of life

    2 years

  • Disease recurrence and survival

    5 years

Study Arms (1)

Neoadjuvant systemic and peritoneal chemotherapy

EXPERIMENTAL

Standard neoadjuvant systemic and pressurised intraperitoneal aerosol chemotherapy

Drug: Doxorubicin and Cisplatin

Interventions

Doxorubicin and CisplatinDRUG

Pressurised intraperitoneal aerosol chemotherapy

Also known as: Adriamycin
Neoadjuvant systemic and peritoneal chemotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gastric adenocarcinoma (Tx, Nx) 1,2,3
  • Peritoneal cytology +ve or PCI ≤ 3
  • No solid organ metastasis 2
  • HER2 -ve
  • Male/female
  • Treatment naïve
  • BMI ≥ 18.5 kg/m2 or ≤ 40 kg/m2
  • WHO performance status ≤ 1
  • Dysphagia score ≤ 2
  • Informed written consent

You may not qualify if:

  • PCI ≥ 4
  • Solid organ metastasis
  • Positive lymph node disease beyond field of D2 lymphadenectomy
  • Peritoneal adhesions precluding complete laparoscopy
  • Ascites (greater than trace amount)
  • Malignant pleural effusion
  • Mechanical bowel obstruction (with the exception of gastric outlet obstruction)
  • HER2 +ve
  • Patients eligible for immunotherapy
  • Uncontrolled co-morbidity
  • single/multiple organ failure
  • BMI \< 18.5 kg/m2 or \> 40 kg/m2
  • WHO performance status \> 1
  • Dysphagia score \> 2
  • Contraindication to chemotherapy
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London, Hammersmith Hospital Campus

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

DoxorubicinCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • George B Hanna, FRCS, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Piers R Boshier, FRCS, PhD

CONTACT

020 7594 8197prb03@ic.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2022

First Posted

April 8, 2022

Study Start

November 1, 2023

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2030

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)