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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00003702
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
* Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers
* Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
* Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum)
* Histologically proven nonmetastatic choriocarcinoma
* Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm)
* WHO score 0-6 (not including blood group or CT lung)
* No histologically confirmed placental site pseudotumor
* Must have undergone at least 1 uterine curettage
* Previously untreated disease
* Performance status - GOG 0-2
* WBC at least 3,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGPT and SGOT no greater than 3 times ULN
* Alkaline phosphatase no greater than 3 times ULN
* No significant prior abnormal hepatic function
* Creatinine no greater than 2.0 mg/dL
* No significant prior abnormal renal function
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for one year after study entry
* No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer
* No prior chemotherapy for gestational trophoblastic neoplasia
* No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00003702
Study Brief:
Protocol Section:
NCT00003702