Aerosol chemotherapy for advanced gastric cancer treatment
Single-center Randomized Study Evaluating of Oncological Benifits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Locally Advanced Gastric Cancer in Patients With Cyt-.
This study is testing a new way of delivering chemotherapy directly to tumors in people with advanced stomach cancer to see if it helps them live longer and feel better compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | St. Petersburg State Pavlov Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT04595929 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) combined with standard neoadjuvant chemotherapy in patients with advanced gastric cancer. Participants aged 18 to 75 with resectable stomach adenocarcinoma will be randomized into two groups: one receiving standard treatment and the other receiving PIPAC in addition to standard treatment. The study aims to evaluate overall survival, median survival, disease-free survival, and quality of life among participants. By utilizing a novel method of delivering chemotherapy directly to tumor sites, the trial seeks to improve outcomes for patients facing peritoneal carcinomatosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed, operable, and resectable gastric adenocarcinoma at stages T3-4.
Not a fit: Patients with prior cytotoxic or targeted therapy or those who have undergone tumor resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly extend survival and improve quality of life for patients with advanced gastric cancer.
How similar studies have performed: While PIPAC is a relatively novel approach, preliminary studies have shown promising results in similar contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint Petersburg
- First Pavlov State Medical University of St. Petersburg — Saint Petersburg, Russia (Recruiting)
Study contacts
- Principal investigator: Alexander Zakharenko, PhD — First Pavlov State Medical University of St. Petersburg
- Study coordinator: Alexander Zakharenko, PhD
- Email: 9516183@mail.ru
- Phone: 9219516183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.