Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Collaborators: Huazhong University of Science and Technology; Qilu Hospital of Shandong University; West China Second University Hospital
• Treatments: Dactinomycin; Methotrexate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.