Clinical trial NCT03885388: Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6
Official title: Women's Hospital, Zhejiang University School of Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gestational Trophoblastic Tumor
Effects of Chemotherapy
Drug Toxicity
Keywords: GTN
MTX
ACTD
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Huazhong University of Science and Technology
name: Qilu Hospital of Shandong University
name: West China Second University Hospital
First posted: 2019-03-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: treatment by combination of methotrexate and actinomycin
Primary purpose: TREATMENT

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.

Detailed description: The improved prognostic scoring system has been in use for more than 20 years in GTN patients. However, there are also more and more clinical evidences showing that the International Federation of Obstetrics and Gynecology（FIGO）/world health organization (WHO) system is not so perfect. The main problem is that a considerable number of patients are resistant to initial chemotherapy, 25-35% occur in low risk (≤ 6 points), and 70-80% occur in patients with a score of 5-6 points. According to reference, the drug resistance factors include high HCG level before chemotherapy, metastatic foci, histological diagnosis of choriocarcinoma, etc. However, according to the score before 2000, there is a moderate risk score group with 4-6 points, i.e. most of the single drug resistance to the initial regimen occurs in the previous moderate risk score group.Therefore, most scholars believe that there are grey areas with a score of 5-6. According to the analysis of 5-6 scores in the scoring system, the prognosis of single-drug chemotherapy is poor, and the initial remission rate is only about 30-40%. Therefore, many authors call for the current staging scoring system to be revised to a more accurate model so that some patients who may be drug resistant can adopt more effective plans at the beginning of treatment.

In this study, the investigators plan to conduct a prospective, multicenter randomized controlled study 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. The experiment arm of the trial is multi-course combination of MTX and ACTD. The primary endpoint is complete remission rate of primary treatment or failure of primary treatment. Drug toxicity is surveillanced.

Eligibility 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.

Primary outcomes:
measure: primary complete remission
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Weiguo Lv
state: Zhejiang
Study officials:
affiliation: Women's Hospital, College of Medicine Zhejiang University
name: Weiguo Lu, MD.
role: STUDY_CHAIR
References: