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:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT04461457
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have histologically confirmed ovarian or tubal or primary peritoneal adenocarcinoma.
2. Patients must have a recurrent intraperitoneal cancer and treated by a salvage chemotherapy to complete or good partial remission
3. The following laboratory and clinical results within 2 weeks prior to first study day:
Absolute neutrophil count (ANC) \> 1.5 x 109/L Platelet count \> 100 x 109/L Serum bilirubin \< upper limit of normal(ULN) Aspartate aminotransaminase (ASAT) \< 1.5 x ULN Serum aminotransferase (ALAT) \< 1.5 x ULN Serum creatinine \< 1.5 x upper limit of normal Thyreoglobulin baseline information Thyroid-stimulating hormone (TSH) baseline information T4 baseline information
4. Karnofsky performance status \> 70.
5. Must understand written and spoken Swedish
6. Before any trial-specific procedures or treatment can be performed, the patient must give written informed consent for participation in the trial.
Exclusion Criteria:
1. Active parenchymal disease (distant metastasis) (i.e. stage IV International Federation of Gynecology and Obstetrics (FIGO) classification.
2. Presence of diagnosed extra abdominal metastasis
3. Clinically significant heart disease.
4. Electrocardiographic demonstrating clinically significant arrhythmias.
5. Other serious illnesses, e.g. serious infections requiring antibiotics, coagulation disorders.
6. Chronic inflammatory bowel disease.
7. Chemotherapy, biologic therapy, or immunotherapy within 4 weeks prior
8. Advanced abdominal adherences.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04461457
Study Brief:
Protocol Section:
NCT04461457