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| Name | Class |
|---|---|
| Vilnius University Hospital Santaros Klinikos | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response according to RECIST v 1.1 | Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after third PIPAC procedure | Day 7 after third PIPAC procedure (an average of 15 weeks after start of the study) |
| Compliance to treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Skaiste Tulyte, MD | Vilnius University Hospital Santaros Klinikos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationa Cancer Institute | Vilnius | Vilniaus | 08406 | Lithuania | ||
| Vilnius University hospital Santaros Klinikos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37875869 | Derived | 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. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Proportion of patients able to receive all anticipated treatment (3 PIPACs and 6 cycles of FOLFOX) |
| Through study completion, an average of 28 months |
| Postoperative complication assessed by Clavien-Dindo score | The number of patients with postoperative complications, defined and graded according to Clavien-Dindo classification | Through study completion, an average of 28 months |
| Peritoneal carcinomatosis index and histological regression according to peritoneal regression grading score (PRGS). | A pathologist blinded to clinical outcomes will evaluate histological tumor response using the Peritoneal Regression Grading Score (PRGS): 1-Complete regression without cancer cells; 2-higher response with prevalence of regressive phenomena and only a few residual cancer cells - PRGS; 3-minor response with prevalence of residual cancer cells and poor regressive phenomena; 4-no response to therapy without regressive phenomena. A patient will be considered a responder if any reduction in the PRGS during subsequent biopsies will be recorded. | Through study completion, an average of 28 months |
| Ascites volume | The volume of ascites recorded at every PIPAC procedure. | Through study completion, an average of 28 months |
| Tumor markers | Ca19-9, carcinoembryonic antigen (CEA), Ca72-4 plasma levels measured at different time points. | Through study completion, an average of 28 months |
| Quality of life by EORTC questionnaires | Quality of life by EORTC questionnaires measured at different time points. | Through study completion, an average of 28 months |
| Overall survival | Time from start of the treatment to death | From treatment start to death, assessed up to 24 months |
| Progression-free survival | Time from start of the treatment to progression of the disease | From treatment start to death, assessed up to 24 months |
| Adverse events of chemotherapy drugs | The number of patients with toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 during the study period | Through study completion, an average of 28 months |
| Vilnius |
| Vilniaus |
| 08661 |
| Lithuania |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |