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

A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Trophoblastic Neoplasms
• Intervention / Treatment: Drug: Etoposide; Drug: actinomycin D; Drug: methotrexate; Drug: vincristine; Drug: cyclophosphamide; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lu Weiguo, Doctor; Phone Number: 86-13588819218; Email: lbwg@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Weiguo Lv
      • Contact: Weiguo Lv, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle	Drug: Etoposide; etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle; Other Names: VP-16; Drug: actinomycin D; actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle; Other Names: ACTD; Sanamycin; 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; Other Names: MTX; Drug: vincristine; vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle; Other Names: VCR; Drug: cyclophosphamide; cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle; Other Names: CTX
Experimental: study group; paclitaxel + cisplatin or carboplatin，two weeks a cycle	Drug: Paclitaxel; paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle; Other Names: Taxol; Drug: Cisplatin; cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle; Other Names: DDP; 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; Other Names: CBP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of adverse events as assessed by the WHO	We calculate the adverse events during and after chemotherapy.	3 years
Overall Survival Rate (OR)	We calculate the overall survival rate of high risk GTN patients after chemotherapy.	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.	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	3 years

Collaborators and Investigators

• Sponsor: Weiguo Lv
• Collaborators: Shandong University; Huazhong University of Science and Technology; First Affiliated Hospital of Zhongshan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: December 13, 2015
• First Submitted That Met QC Criteria: December 20, 2015
• First Posted (Estimate): December 24, 2015

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: cisplatin; chemotherapy; paclitaxel; carboplatin; gestational trophoblastic tumor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Pregnancy Complications; Pregnancy Complications, Neoplastic; Trophoblastic Neoplasms; Gestational Trophoblastic Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antibiotics, Antineoplastic; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Cyclophosphamide; Carboplatin; Etoposide; Paclitaxel; Cisplatin; Methotrexate; Vincristine; Dactinomycin
• Other Study ID Numbers: ZJHGTN1211