A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
Overview
- Phase
- Phase 3
- Intervention
- Etoposide
- Conditions
- Gestational Trophoblastic Neoplasms
- Sponsor
- Weiguo Lv
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- complete remission rate in firstline treatment
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Weiguo Lv
Vice-President
Women's Hospital School Of Medicine Zhejiang University
Eligibility Criteria
Inclusion Criteria
- •Patients who International Federation of Gynecology and Obstetrics (FIGO) Stage I, II, or III criteria for high-risk gestational trophoblastic neoplasia (GTN) and stage Ⅳ cases
- •World Health Organization(WHO) risk score ≥7, and less than 13
- •Age≤60 years; female, Chinese women
- •Initial treatment is chemotherapy
- •Performance status: Karnofsky score≥60
- •Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal,blood urea nitrogen, Cr≤ normal
- •Provide written informed consent.
Exclusion Criteria
- •Patients with unconfirmed diagnosis of GTN
- •Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
- •WHO risk score less than 7
- •With severe or uncontrolled internal disease, unable to receive chemotherapy
- •Concurrently participating in other clinical trials
- •Unable or unwilling to sign informed consents
- •Unable or unwilling to abide by protocol
Arms & Interventions
control group
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
Intervention: Etoposide
control group
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
Intervention: actinomycin D
control group
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
Intervention: methotrexate
control group
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
Intervention: vincristine
control group
etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle
Intervention: cyclophosphamide
study group
paclitaxel + cisplatin or carboplatin，two weeks a cycle
Intervention: Paclitaxel
study group
paclitaxel + cisplatin or carboplatin，two weeks a cycle
Intervention: Cisplatin
study group
paclitaxel + cisplatin or carboplatin，two weeks a cycle
Intervention: Carboplatin
Outcomes
Primary Outcomes
complete remission rate in firstline treatment
Time Frame: 3 years
We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.
Secondary Outcomes
- The pregnancy rate(3 years)
- Overall Survival Rate (OR)(3 years)
- Severity of adverse events as assessed by the WHO(3 years)
- Ovarian functional evaluation(every 6 months up to 3 years)