Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic … (NCT03885388) | Clinical Trial Compass
UnknownPhase 2/3
Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma (GTN) Patients With Score of 5-6
China300 participantsStarted 2019-03-08
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ETTï¼›
* 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.
What they're measuring
1
primary complete remission
Timeframe: 24 weeks
Trial details
NCT IDNCT03885388
SponsorWomen's Hospital School Of Medicine Zhejiang University