Clinical trial NCT05644249: PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer
Official title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Systemic Chemotherapy as a First-line Treatment for Gastric Cancer Peritoneal Metastases: Open-label, Single-arm, Multi-center Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Peritoneal Carcinomatosis
Keywords: Gastric cancer
Peritoneal carcinomatosis
PIPAC
FOLFOX
Bidirectional
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Vilnius University Hospital Santaros Klinikos
name: National Cancer Institute (NCI)
First posted: 2022-12-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective tumor response according to RECIST v 1.1 after second PIPAC
timeFrame: Day 7 after second PIPAC procedure (an average of 8 weeks after start of the study)
Secondary outcomes:
measure: Objective tumor response according to RECIST v 1.1
timeFrame: Day 7 after third PIPAC procedure (an average of 15 weeks after start of the study)
measure: Compliance to treatment
timeFrame: Through study completion, an average of 28 months
measure: Postoperative complication assessed by Clavien-Dindo score
timeFrame: Through study completion, an average of 28 months
measure: Peritoneal carcinomatosis index and histological regression according to peritoneal regression grading score (PRGS).
timeFrame: Through study completion, an average of 28 months
measure: Ascites volume
timeFrame: Through study completion, an average of 28 months
measure: Tumor markers
timeFrame: Through study completion, an average of 28 months
measure: Quality of life by EORTC questionnaires
timeFrame: Through study completion, an average of 28 months
measure: Overall survival
timeFrame: From treatment start to death, assessed up to 24 months
measure: Progression-free survival
timeFrame: From treatment start to death, assessed up to 24 months
measure: Adverse events of chemotherapy drugs
timeFrame: Through study completion, an average of 28 months
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Nationa Cancer Institute
state: Vilniaus
city: Vilnius
country: Lithuania
facility: Vilnius University hospital Santaros Klinikos
state: Vilniaus
Study officials:
affiliation: Vilnius University Hospital Santaros Klinikos
name: Skaiste Tulyte, MD
role: PRINCIPAL_INVESTIGATOR
References: