BridgeMD
New treatment option for Peritoneal Carcinomatosis
Official title Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-
ClinicalTrials.gov ID: NCT04595929
What this study is testing
What is 5-Fluorouracil?
5-Fluorouracil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peritoneal carcinomatosis.
Also referred to as 5-FU.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- ECOG = 0-2.
You likely can't join if
- 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)...
See the full eligibility 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...
- 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...
- 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...
- Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures.
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.