Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neopl… (NCT00003702) | Clinical Trial Compass
CompletedPhase 3
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
United States240 participantsStarted 1999-06
Plain-language summary
Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 chemotherap…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
Timeframe: Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.
2
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
Timeframe: Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.