Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT07282834
Eligibility Criteria:
Inclusion Criteria:
1. Males or females age 18 to 80 years.
2. Biopsy-proven or clinically suspected peritoneal carcinomatosis
3. Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
4. Not a candidate for surgical cytoreduction at the time of laparoscopy
5. 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), Depo-Provera, or an oral contraceptive, for the duration of the study.
6. Must be able to read and understand English and consent for themselves
Exclusion Criteria:
1. Patients who are eligible for definitive cytoreductive surgery at the time of enrollment
2. 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 \> 2.5 times the upper limit of normal Hemoglobin \< 7 gm/dL White blood cell count \< 3,000/ mm3 Platelet count \< 50,000/mm3
3. Any investigational drug use within 30 days prior to enrollment.
4. Systemic therapy within 14 days prior to randomization
5. Allergy or medical contra-indication to chemotherapy utilized in this study
6. Medical contraindication to laparoscopic surgery or complex cytoreductive surgery
7. Pregnant or lactating females.
8. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07282834
Study Brief:
Protocol Section:
NCT07282834