PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer

NCT05644249 | Completed

• 1 other identifier: V1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastric Cancer; Peritoneal Carcinomatosis

Keywords

Gastric cancer; Peritoneal carcinomatosis; PIPAC; FOLFOX; Bidirectional

Outcome Measures

Primary Outcomes (1)

• Objective tumor response according to RECIST v 1.1 after second PIPAC

  Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after second PIPAC procedure

  Day 7 after second PIPAC procedure (an average of 8 weeks after start of the study)

Secondary Outcomes (10)

• Objective tumor response according to RECIST v 1.1

  Day 7 after third PIPAC procedure (an average of 15 weeks after start of the study)

• Compliance to treatment

  Through study completion, an average of 28 months

• Postoperative complication assessed by Clavien-Dindo score

  Through study completion, an average of 28 months

• Peritoneal carcinomatosis index and histological regression according to peritoneal regression grading score (PRGS).

  Through study completion, an average of 28 months

• Ascites volume

  Through study completion, an average of 28 months

Study Arms (1)

Experimental treatment

EXPERIMENTAL

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.

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

Interventions

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

Also known as: PIPAC

Experimental treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis;
• Age≥18;
• ECOG≤1;
• Patient willing to participate;
• Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.

You may not qualify if:

• Extra-abdominal metastases;
• Siewert I type gastroesophageal junction cancer;
• Mechanical bowel obstruction;
• Allergy to study drugs;
• History of previous intraperitoneal chemotherapy;
• Pregnancy of refusal for birth-control at least 6 months post-study treatment

Sponsors & Collaborators

• Vilnius University: lead
• Vilnius University Hospital Santaros Klinikos: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Nationa Cancer Institute

Vilnius, Vilniaus, 08406, Lithuania

Location

Vilnius University hospital Santaros Klinikos

Vilnius, Vilniaus, 08661, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 37875869 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Study Officials

• Skaiste Tulyte, MD

  Vilnius University Hospital Santaros Klinikos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Abdominal surgeon

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: December 9, 2022
• Study Start: December 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

LI (2)