Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

Weiguo Lv

Status and phase: Enrolling; Phase 3

Conditions: Gestational Trophoblastic Neoplasms

Treatments: Drug: methotrexate; Drug: actinomycin D; Drug: Paclitaxel; Drug: cyclophosphamide; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Drug: vincristine

Study type: Interventional

Funder types: Other

Identifiers

NCT02639650

ZJHGTN1211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 estimated patients

Sex: Female

Ages: Under 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

control group

Active Comparator group

Description:

etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle

Treatment:

Drug: vincristine

Drug: Etoposide

Drug: methotrexate

Drug: cyclophosphamide

Drug: actinomycin D

study group

Experimental group

Description:

paclitaxel + cisplatin or carboplatin，two weeks a cycle

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Paclitaxel