Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6
Women's Hospital, Zhejiang University School of Medicine
1 other identifier
interventional
300
1 country
1
Brief Summary
In this study, a prospective, multicenter randomized controlled study was conducted to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2019
CompletedFirst Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 21, 2019
March 1, 2019
2.8 years
March 18, 2019
March 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
primary complete remission
complete remission rate by primary treatment
24 weeks
Study Arms (2)
control arm
ACTIVE COMPARATORsingle methotrexate multicourse treatment MTX:MTX 0.4mg/kg•d, intramuscular, every two weeks
experimental arm
EXPERIMENTALcombination of methotrexate and actinomycin multicourse treatment, every two weeks MTX+ACTD:Act-d 0.6mg/m2 Day1,2 intravenous (IV) MTX 100mg/m2 IV Day1(after Act-d) MTX 200mg/m2 Ivgtt Day1(after MTX,500mlNS)
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of gestational trophoblastic tumor;
- Patients with prognosis score of 5 and 6
- Primary chemotherapy (preventive chemotherapy is not included);
- Physical strength grade: Karnofsky score ≥ 60;
- WBC ≥ 3.5× 109/L, ANC ≥ 1.5× 109/L, PT ≥ 80× 109/L, serum bilirubin ≤ 1.5 times of normal high limit, transaminase ≤ 1.5 times of normal high limit, BUN, Cr≤ normal;
- Follow-up and good compliance;
- Sign the informed consent form.
You may not qualify if:
- Pathological diagnosis is intermediate trophoblastic tumor, including PSTT and ETT；
- There are serious or uncontrollable medical diseases, which are not suitable for chemotherapy;
- Those who receive clinical trials of other drugs at the same time.
- Those who receive Chinese medicine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weiguo Lv
Hangzhou, Zhejiang, 310006, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weiguo Lu, MD.
Women's Hospital, College of Medicine Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 21, 2019
Study Start
March 8, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2023
Last Updated
March 21, 2019
Record last verified: 2019-03