A Phase 3 interventional study of Etoposide and actinomycin D in Gestational Trophoblastic Neoplasms, sponsored by Weiguo Lv. Recruiting at 1 site in China. Open to female participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Weiguo Lv · Phase 3, Interventional, and Treatment
This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.
Gestational trophoblastic tumor (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which occur in women of reproductive age. The survival rate of patients with score of 7 or more points, or WHO Ⅳ period for high-risk patients was of 60% to 80%. However, due to severe toxic reactions, long treatment time, loss of optimal reproductive age and increased costs, and treatment failure caused by chemotherapy resistance, high-risk GTN is still one of the tumors seriously affecting the life health and quality of life of young women.
First-line chemotherapy recommended by FIGO is regimen of EMA - CO with corresponding side effects and adverse factors in the following aspects as relatively higer incidence of myelosupression, VP - 16 being associated with a second tumor, especially leukemia, and a definite effect of cyclophosphamide on the failure ovarian function Taxol (Taxol) is the most widely used and most effective broad-spectrum anti-tumor drug in gynecological malignant tumors at present, and T (paclitaxel) +P (platinum drugs) scheme is the first-line chemotherapy scheme in ovarian cancer patients at present. According to references, TP also has effects on resistant and refactory high risk GTN patients.
Given relatively simple operation way of TP chemotherapy, and the effect of chemotherapy in recurrence and high-risk refractory GTN performance,this prospective multicenter randomized controlled clinical research was to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor compared with EMA-CO.
Exclusion Criteria:
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
Drug: Etoposide · Drug: actinomycin D · Drug: methotrexate · Drug: vincristine · Drug: cyclophosphamide
paclitaxel + cisplatin or carboplatin，two weeks a cycle
Drug: Paclitaxel · Drug: Cisplatin · Drug: Carboplatin
etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle
Also known as: VP-16
actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle
Also known as: ACTD, Sanamycin
methotrexate 100mg/m2, 200mg/m2, ivgtt, tetrahydrofolic acid （FA) 15mg q12h\*4(24h after methotrexate injection),started at the first day of cycle, two weeks a cycle
Also known as: MTX
vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle
Also known as: VCR
cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle
Also known as: CTX
paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle
Also known as: Taxol
cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle
Also known as: DDP
carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin
Also known as: CBP
complete remission rate in firstline treatment
We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.
Time frame: 3 years
Severity of adverse events as assessed by the WHO
We calculate the adverse events during and after chemotherapy.
Time frame: 3 years
Overall Survival Rate (OR)
We calculate the overall survival rate of high risk GTN patients after chemotherapy.
Time frame: 3 years
Ovarian functional evaluation
We may test serum level of anti-mullerian hormone (AMH) every 6 months and the time of menstrual cycle resuming after chemotherapy.
Time frame: every 6 months up to 3 years
The pregnancy rate
To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail
Time frame: 3 years
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