NCT04562558

Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia

A Prospective，Multicenter，Randomized Trial of Biweekly Single-dose Actinomycin-D Versus Multi-day Methotrexate Protocol for the Treatment of Low-risk Gestational Trophoblastic Neoplasia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: xiang yang · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators conducted a randomized trial to study how well multi-day methotrexate protocol works compared to biweekly single-dose actinomycin D protocol in treating patients with low-risk gestational trophoblastic neoplasia. It is not yet known whether multi-day methotrexate protocol is as effective as biweekly single-dose actinomycin D protocol in treating patients with gestational trophoblastic neoplasia.

Conditions

• Gestational Trophoblastic Tumor
• Gestational Trophoblastic Neoplasia
• Stage I Gestational Trophoblastic Tumor
• Stage II Gestational Trophoblastic Tumor
• Stage III Gestational Trophoblastic Tumor
• Invasive Mole
• Choriocarcinoma

Interventions

Type	Name	Description
DRUG	Methotrexate	50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days
DRUG	Leucovorin	15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days
DRUG	Dactinomycin	1.25mg/m2 (2mg max dose)intravenous every 14 days.

Timeline

• Start date: 2020-09-29
• Primary completion: 2024-11-11
• Completion: 2025-12-01
• First posted: 2020-09-24
• Last updated: 2025-08-11

Locations

1 site across 1 country: China