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

NCT04562558 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-08-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • xiang yang

    lead OTHER

Principal Investigators

  • yang xiang · Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2024-11-11
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562558 on ClinicalTrials.gov