Gestational Trophoblastic Neoplasms
Conditions
Keywords
gestational trophoblastic tumor, paclitaxel, cisplatin, carboplatin, chemotherapy
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.
Interventions
DRUGEtoposide
etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle
DRUGactinomycin D
actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle
DRUGmethotrexate
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
DRUGvincristine
vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle
DRUGcyclophosphamide
cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle
DRUGPaclitaxel
paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle
DRUGCisplatin
cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle
DRUGCarboplatin
carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin
Sponsors
Shandong University
Huazhong University of Science and Technology
First Affiliated Hospital of Zhongshan Medical University
Weiguo Lv
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate in firstline treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Severity of adverse events as assessed by the WHO | 3 years | We calculate the adverse events during and after chemotherapy. |
| Overall Survival Rate (OR) | 3 years | We calculate the overall survival rate of high risk GTN patients after chemotherapy. |
| Ovarian functional evaluation | every 6 months up to 3 years | We may test serum level of anti-mullerian hormone (AMH) every 6 months and the time of menstrual cycle resuming after chemotherapy. |
| The pregnancy rate | 3 years | To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail |
Countries
China
Contacts
Primary ContactLu Weiguo, Doctor
Outcome results
None listed