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

NCT02639650 | Recruiting Phase 3

• 1 other identifier: ZJHGTN1211
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Trophoblastic Neoplasms

Keywords

gestational trophoblastic tumor; paclitaxel; cisplatin; carboplatin; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Severity of adverse events as assessed by the WHO

  3 years

• Overall Survival Rate (OR)

  3 years

• Ovarian functional evaluation

  every 6 months up to 3 years

• The pregnancy rate

  3 years

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Drug: Etoposide; Drug: actinomycin D; Drug: methotrexate; Drug: vincristine; Drug: cyclophosphamide

study group

EXPERIMENTAL

paclitaxel + cisplatin or carboplatin，two weeks a cycle

Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin

Interventions

Etoposide DRUG

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

Also known as: VP-16

control group

actinomycin D DRUG

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

Also known as: ACTD, Sanamycin

control group

methotrexate 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

Also known as: MTX

control group

vincristine DRUG

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

Also known as: VCR

control group

cyclophosphamide DRUG

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

Also known as: CTX

control group

Paclitaxel DRUG

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

Also known as: Taxol

study group

Cisplatin DRUG

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

Also known as: DDP

study group

Carboplatin 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

Also known as: CBP

study group

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weiguo Lv: lead
• Shandong University: collaborator
• Huazhong University of Science and Technology: collaborator
• First Affiliated Hospital of Zhongshan Medical University: collaborator

Study Sites (1)

Weiguo Lv

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Gestational Trophoblastic Disease

Interventions

Etoposide; Dactinomycin; Methotrexate; Vincristine; Cyclophosphamide; Paclitaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Central Study Contacts

Lu Weiguo, Doctor

CONTACT

86-13588819218; lbwg@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-President

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: December 24, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2026
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

CN (1)