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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT00838656
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Clinically, radiologically, and histologically confirmed diagnosis of 1 of the following:
* Primary epithelial ovarian cancer
* Primary peritoneal carcinoma
* Ovarian carcinosarcoma
* Fallopian tube carcinoma
* Newly diagnosed, stage IIIC/IV disease with or without ascites
* None of the following histologies allowed:
* Mucinous
* Classic clear cell
* Micropapillary or microacinar borderline tumors with or without invasive implants
* Unsuitable for primary debulking surgery, as defined by the following:
* Laparoscopic or other minor surgical-staging procedures
* Supplementary clinical and radiological assessments
* Presenting with factors affecting suitability for successful complete resection and necessarily prompting laparoscopic assessment, including any of the following:
* CT scan or MRI evidence of peritoneal carcinomatosis, extensive mesenteric infiltration, diaphragmatic involvement, extensive retroperitoneal involvement, and cytologically verified malignant pleural effusion and/or ascites
* Clinical evidence of ascites with radiological evidence of multisite disease
* Clinical evidence of pelvic infiltration and radiological evidence of multisite disease
* FIGO stage IV disease, including cervical/supraclavicular lymphadenopathy, intrahepatic parenchymal metastases, or cytologically confirmed malignant pleural effusion
* No known brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Life expectancy ≥ 3 months
* WBC \> 3.0/mm³
* Platelet count ≥ 100,000/mm³
* ANC ≥ 1,500/mm³
* AST and ALT \< 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase \< 2.5 times ULN
* Bilirubin \< 1.5 times ULN
* Estimated glomerular filtration rate ≥ 30 mL/min
* No diabetics, hypertensive smokers, or other patients with pre-existing occult neuropathic deficits
* No poorly controlled, potentially serious medical conditions, including any of the following:
* Cerebrovascular events within the past 12 months
* Severe chronic respiratory conditions requiring prior hospitalization
* Active infections
* Poorly controlled seizures
* Morbid psychiatric conditions likely to render treatment compliance with the protocol difficult
* No other malignancy treated with chemotherapy or radiotherapy except nonmelanoma skin cancer or carcinoma in situ of the cervix
* Prior malignancies disease-free for \> 5 years not treated with chemotherapy allowed
* No other reasons likely to cause inability to comply with treatment schedule and follow-up
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00838656
Study Brief:
Protocol Section:
NCT00838656