Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

Gestational Trophoblastic Tumor Clinical Trial

— GTN-01  

Official title:

A Multicenter, Prospective, Randomized Trial of Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01823315
• Other study ID #: 2012-GYN/GTN-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators conducted a trial to determine whether methotrexate or methotrexate/dactinomycin single-course treatment work well as multiple courses of single methotrexate chemotherapy in low-risk gestational trophoblastic neoplasia. It is not yet known whether single-course of chemotherapy is as the same effectiveness as multicourse.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients who FIGO Stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN);

• WHO risk score 0-6;

• Age=60 years; female, Chinese women;

• Initial treatment is chemotherapy; patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study;

• 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, BUN, 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 >6;

• 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.

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Neoplasia
• Gestational Trophoblastic Neoplasms
• Gestational Trophoblastic Tumor
• Neoplasms
• Trophoblastic Neoplasms

Intervention

Drug:
• MTX 1
MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5
• MTX 2
MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, >4h)

Biological:
• Act-d
Act-d 0.6mg/m(2), IV, on day1,2

Locations

Country	Name	City	State
China	Women's Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Qilu Hospital,Shandong University	Jinan	Shandong
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Ding Ma	Huazhong University of Science and Technology, Shandong University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response (CR) by single-course		through study completion, an average of 1 year
Primary	Completely remission rate by multiple courses after single-course failure		through study completion, an average of 1 year
Secondary	remission rate of ACTD replacement after MTX resistance		through study completion, an average of 1 year
Secondary	the number of courses needed to achieve complete remission after multi-course treatment		through study completion, an average of 1 year
Secondary	complete remission rate by multidrug combination therapy after single drug failure		through study completion, an average of 1 year