NCT04595929 Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-
| NCT ID | NCT04595929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Petersburg State Pavlov Medical University |
| Condition | Peritoneal Carcinomatosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 304 participants |
| Start Date | 2020-02-10 |
| Primary Completion | 2021-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 304 participants in total. It began in 2020-02-10 with a primary completion date of 2021-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed, medically operable, resectable stomach adenocarcinoma (cT3-4, any N category, M0). * No preceding cytotoxic or targeted therapy. * No prior partial or complete tumor resection. * Female and male patient ≥ 18 and ≤ 75 years. Female patient with childbearing potential needs to have a negative pregnancy test within 7 days prior to study start. Males and females of reproductive potential must agree to practice highly effective contraceptive measures\* during the study. Male patients must also agree to refrain from father a child during treatment and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure. \*highly effective (i.e. failure rate of \<1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments). * ECOG = 0-2. * Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI. * Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start of FLOT chemotherapy * Adequate hematological, hepatic and renal function parameters: Leukocytes ≥ 3000/mm³, platelets ≥ 100,000/mm³, neutrophil count (ANC) ≥1000/µL Serum creatinine ≤ 1.5 x upper limit of normal Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN; for patients receiving therapeutic anticoagulation: stable anticoagulant regimen. * Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures. Exclusion Criteria: * Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT. * Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel. * Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel. * Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV. * Clinically significant valvular defect. * Criteria of primary unresectability, e.g.: Radiologically documented evidence of major blood vessel invasion or invasion of adjacent organs (T4b). Patients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastases!). * Other severe internal disease or acute infection. * Peripheral polyneuropathy ≥ NCI Grade II. * Patient has undergone major surgery within 28 days prior to enrollment except staging laparoscopy. * Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites. * On-treatment participation in another interventional clinical study in the period 30 days prior to inclusion and during the study. * Patient pregnant or breast feeding, or planning to become pregnant. * Any other concurrent antineoplastic treatment including irradiation.
Contact & Investigator
Alexander Zakharenko, PhD
PRINCIPAL INVESTIGATOR
First Pavlov State Medical University of St. Petersburg
Frequently Asked Questions
Who can join the NCT04595929 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Peritoneal Carcinomatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04595929 currently recruiting?
Yes, NCT04595929 is actively recruiting participants. Contact the research team at 9516183@mail.ru for enrollment information.
Where is the NCT04595929 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT04595929 clinical trial?
NCT04595929 is sponsored by St. Petersburg State Pavlov Medical University. The principal investigator is Alexander Zakharenko, PhD at First Pavlov State Medical University of St. Petersburg. The trial plans to enroll 304 participants.