PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer

NCT ID: NCT05644249

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-09-01

Brief Summary

Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a modern treatment modality for PC, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. Despite some encouraging preliminary results for PIPAC efficacy, it is still an investigational treatment. Furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and PIPAC. Thus, this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.

Detailed Description

This open-label, single-arm feasibility study will be conducted at two major gastrointestinal cancer treatment centers in Lithuania and will include 37 participants. Gastric cancer patients diagnosed with a synchronous or metachronous peritoneal carcinomatosis based on a clinical, radiological, cytological, and histological examination will be considered for enrollment. Thirty-seven patients willing to participate and meeting the enrollment criteria will be scheduled for the experimental treatment. Three cycles of 1st line palliative systemic chemotherapy will be administered every 28 days and PIPAC with cisplatin 10,5 mg/m2 and doxorubicin 2,1 mg/m2 will be utilized 14 days after each of the systemic chemotherapy cycles. After the 3rd PIPAC procedure patients will be re-assessed and discussed at multidisciplinary team meetings. In case of downstaging patients will be considered for radical gastrectomy±cytoreductive surgery; others for further systemic therapy. All patients will be followed up for 24 months.

Conditions

Gastric Cancer; Peritoneal Carcinomatosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental treatment

Each patient will be scheduled for 3 courses of combined treatment: in total 3 PIPAC with cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 and 6 cycles of FOLFOX systemic chemotherapy.

Group Type: EXPERIMENTAL

Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy

Intervention Type: DRUG

Each course of combined treatment will start with PIPAC (a pressurized aerosol containing cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 diluted in NaCl 0.9% applied through the nebulizer inside the abdominal cavity during laparoscopy). Fourteen days afterward 2 cycles of systemic FOLFOX chemotherapy will be applied within 28 days. The interval between combined treatment courses will be 14 days.

Interventions

Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy

Each course of combined treatment will start with PIPAC (a pressurized aerosol containing cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 diluted in NaCl 0.9% applied through the nebulizer inside the abdominal cavity during laparoscopy). Fourteen days afterward 2 cycles of systemic FOLFOX chemotherapy will be applied within 28 days. The interval between combined treatment courses will be 14 days.

Intervention Type: DRUG

Other Intervention Names

PIPAC

Eligibility Criteria

Inclusion Criteria

1. Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis;

2. Age≥18;

3. ECOG≤1;

4. Patient willing to participate;

5. Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.

Exclusion Criteria

1. Extra-abdominal metastases;

2. Siewert I type gastroesophageal junction cancer;

3. Mechanical bowel obstruction;

4. Allergy to study drugs;

5. History of previous intraperitoneal chemotherapy;

6. Pregnancy of refusal for birth-control at least 6 months post-study treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Martynas Luksta

Abdominal surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Skaiste Tulyte, MD

Role: PRINCIPAL_INVESTIGATOR

Vilnius University Hospital Santaros Klinikos

Locations

Nationa Cancer Institute

Vilnius, Vilniaus, Lithuania

Vilnius University hospital Santaros Klinikos

Vilnius, Vilniaus, Lithuania

Countries

Lithuania

References

Luksta M, Bausys A, Bickaite K, Rackauskas R, Paskonis M, Luksaite-Lukste R, Ranceva A, Stulpinas R, Brasiuniene B, Baltruskeviciene E, Lachej N, Sabaliauskaite R, Bausys R, Tulyte S, Strupas K. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study. BMC Cancer. 2023 Oct 25;23(1):1032. doi: 10.1186/s12885-023-11549-z.

Reference Type: DERIVED

PMID: 37875869 (View on PubMed)

Other Identifiers

V1

Identifier Type: -

Identifier Source: org_study_id