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Compares treatment options for Peritoneal (Metastatic) Cancer
Official title Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)
ClinicalTrials.gov ID: NCT07282834
What this study is testing
- What it's testing
- This research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
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 80
You may be able to join if
- Males or females age 18 to 80 years.
- Biopsy-proven or clinically suspected peritoneal carcinomatosis
- Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
- Not a candidate for surgical cytoreduction at the time of laparoscopy
- Women at least 18 years of age of childbearing potential must have a negative urine/serum pregnancy test and must use an acceptable method of...
You likely can't join if
- Patients who are eligible for definitive cytoreductive surgery at the time of enrollment
- Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease: AST/SGOT \> 2.5 times the upper limit of...
- Any investigational drug use within 30 days prior to enrollment.
- Systemic therapy within 14 days prior to randomization
- Allergy or medical contra-indication to chemotherapy utilized in this study
- Medical contraindication to laparoscopic surgery or complex cytoreductive surgery
See the full eligibility criteria
- Males or females age 18 to 80 years.
- Biopsy-proven or clinically suspected peritoneal carcinomatosis
- Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
- Not a candidate for surgical cytoreduction at the time of laparoscopy
- Women at least 18 years of age of childbearing potential must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom)...
- Must be able to read and understand English and consent for themselves
- Patients who are eligible for definitive cytoreductive surgery at the time of enrollment
- Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease: AST/SGOT \> 2.5 times the upper limit of normal ALT/SGPT \> 2.5 times the upper limit of normal Total bilirubin...
- Any investigational drug use within 30 days prior to enrollment.
- Systemic therapy within 14 days prior to randomization
- Allergy or medical contra-indication to chemotherapy utilized in this study
- Medical contraindication to laparoscopic surgery or complex cytoreductive surgery
- Pregnant or lactating females.
- people who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. 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.