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Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer

ConditionsGastric CancerPeritoneal MetastasesChemotherapy Effect
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorImperial College London

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gastric adenocarcinoma (Tx, Nx) 1,2,3

Peritoneal cytology +ve or PCI ≤ 3

No solid organ metastasis 2

HER2 -ve

Disqualifiers

PCI ≥ 4

Solid organ metastasis

Positive lymph node disease beyond field of D2 lymphadenectomy

Peritoneal adhesions precluding complete laparoscopy

Trial design

Design model

Single group

Treatments tested in this trial

  • Doxorubicin and Cisplatin

    Drug

    Pressurised intraperitoneal aerosol chemotherapy

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Neoadjuvant systemic and peritoneal chemotherapyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

1

Tumour regression

Regression of peritoneal tumour deposits and/or positive peritoneal cytology. Regression will be assesses visually at the time of laparoscopy, by appropriate cross sectional imaging and through histological assessment of acquired samples.

Time frame
2 years
2

Patient morbidity

Common Toxicity Criteria and Common Terminology Criteria for Adverse Events (Ver. 5) will be used to grade any complications that occur as a consequence of systemic chemotherapy and PIPAC administration. Surgical complications will reported using standard terminologies and graded using the Clavien-Dindo system.

Time frame
2 years
3

Health related quality of life

Health related quality of life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) generic questionnaire QLQ-C30 (version 3.0).

Time frame
2 years
4

Disease recurrence and survival

Peritoneal disease recurrence (assessed by conventional methods), overall and disease-free survival following radical gastrectomy.

Time frame
5 years

Other outcomes

Sponsors and contacts

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Imperial College London

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: