Clinical trial · Interventional
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
NCT00003702CI-TRIAL-00032930completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Good Prognosis Metastatic Gestational Trophoblastic Tumor | — | UNRESOLVED | — |
| Hydatidiform Mole | Molar Pregnancy | ALIAS | 0.90 |
| Non-Metastatic Gestational Trophoblastic Tumor | — | UNRESOLVED | — |
| Uterine Corpus Choriocarcinoma | Uterine Corpus Choriocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dactinomycin | Biological | Dactinomycin | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (methotrexate)
- description
- Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
- interventionNames
- Drug: Methotrexate
- type
- EXPERIMENTAL
- label
- Arm II (dactinomycin)
- description
- Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
- interventionNames
- Biological: Dactinomycin
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.