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

NCT ID: NCT02639650

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2026-03-01

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.

Conditions

Gestational Trophoblastic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

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

Group Type: ACTIVE_COMPARATOR

Etoposide

Intervention Type: DRUG

etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle

actinomycin D

Intervention Type: DRUG

actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle

methotrexate

Intervention Type: DRUG

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

vincristine

Intervention Type: DRUG

vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle

cyclophosphamide

Intervention Type: DRUG

cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle

study group

paclitaxel + cisplatin or carboplatin，two weeks a cycle

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle

Cisplatin

Intervention Type: DRUG

cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle

Carboplatin

Intervention Type: DRUG

carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin

Interventions

Etoposide

etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle

Intervention Type: DRUG

actinomycin D

actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle

Intervention Type: DRUG

methotrexate

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

Intervention Type: DRUG

vincristine

vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle

Intervention Type: DRUG

cyclophosphamide

cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle

Intervention Type: DRUG

Paclitaxel

paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle

Intervention Type: DRUG

Cisplatin

cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle

Intervention Type: DRUG

Carboplatin

carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin

Intervention Type: DRUG

Other Intervention Names

VP-16; ACTD; Sanamycin; MTX; VCR; CTX; Taxol; DDP; CBP

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

• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhongshan Medical University

OTHER

Sponsor Role: collaborator

Weiguo Lv

OTHER

Sponsor Role: lead

Responsible Party

Weiguo Lv

Vice-President

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Weiguo Lv

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lu Weiguo, Doctor

Role: CONTACT

lbwg@zju.edu.cn

86-13588819218

Facility Contacts

Weiguo Lv, Doctor

Role: primary

Other Identifiers

ZJHGTN1211

Identifier Type: -

Identifier Source: org_study_id