PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer

Last updated: January 3, 2023
Sponsor: Vilnius University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Carcinoma

Peritoneal Cancer

Treatment

N/A

Clinical Study ID

NCT05644249
V1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically verified gastric adenocarcinoma (HER2 negative) with peritonealcarcinomatosis;
  2. Age≥18;
  3. ECOG≤1;
  4. Patient willing to participate;
  5. Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.

Exclusion

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

Study Design

Total Participants: 37
Study Start date:
December 01, 2022
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • Nationa Cancer Institute

    Vilnius, Vilniaus 08406
    Lithuania

    Active - Recruiting

  • Vilnius University hospital Santaros Klinikos

    Vilnius, Vilniaus 08661
    Lithuania

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.