Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia

Gestational Trophoblastic Tumor Clinical Trial

Official title:

A Prospective，Multicenter，Randomized Trial of Biweekly Single-dose Actinomycin-D Versus Multi-day Methotrexate Protocol for the Treatment of Low-risk Gestational Trophoblastic Neoplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04562558
• Other study ID #: PUMCH-LRGTN-SINGLE DRUG-0222
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Peking Union Medical College Hospital
• Contact: Yang Xiang
• Phone: 86-010-69155635
• Email: xiangy[@]Pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators conducted a randomized trial to study how well multi-day methotrexate protocol works compared to biweekly single-dose actinomycin D protocol in treating patients with low-risk gestational trophoblastic neoplasia. It is not yet known whether multi-day methotrexate protocol is as effective as biweekly single-dose actinomycin D protocol in treating patients with gestational trophoblastic neoplasia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically proven low-risk gestational trophoblastic neoplasia (persistent

hydatidiform mole or choriocarcinoma), defined as 1 of the following:

• Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers
• Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
• Histologically proven choriocarcinoma
• Stage I - III disease
• WHO risk score 0-4
• No prior chemotherapy for gestational trophoblastic neoplasia
• Signed informed consent
• Performance status - GOG 0-2
• Laboratory examination: WBC=3.5×10(9)/L, Granulocyte count=1.5×10(9)/L, Platelet count=80×10(9)/L, serum bilirubin= 1.5 times the upper limit of normal, transaminase= 1.5 times the upper limit of normal, BUN, Creatinine= normal? Fertile patients must use effective contraception during and for one year after study entry

Exclusion Criteria:

• Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
• primary choriocarcinoma
• WHO risk score >4
• Previous MTX treatment for suspected ectopic pregnancy
• 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

• Choriocarcinoma
• Gestational Trophoblastic Disease
• Gestational Trophoblastic Neoplasia
• Gestational Trophoblastic Tumor
• Invasive Mole
• Neoplasms
• Stage I Gestational Trophoblastic Tumor
• Stage II Gestational Trophoblastic Tumor
• Stage III Gestational Trophoblastic Tumor
• Trophoblastic Neoplasms

Intervention

Drug:
• Methotrexate
50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days
• Leucovorin
15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days
• Dactinomycin
1.25mg/m2 (2mg max dose)intravenous every 14 days.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
xiang yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completely remission (CR) rate by single-agent	Percentage of participants with complete response by single-agent chemotherapy. A complete response was defined as a normal hCG sustained over 3 weekly measurements.	from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy,assessed up to 8 months
Primary	Overall completely remission rate	Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure	from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy or multi-agent chemotherapy,assessed up to 12 months
Secondary	The duration needed to achieve complete remission after single-agent chemotherapy	The duration needed to achieve complete remission after single-agent in two arms	from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy,assessed up to 8 months
Secondary	The number of courses needed to achieve complete remission after single-agent chemotherapy	The number of courses needed to achieve complete remission after single-agent chemotherapy in two arms	from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy,assessed up to 8 months
Secondary	Incidence of Adverse Effects (Grade 3 or Higher)	Incidence and severity of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 in two arms	through study completion, an average of 3 year
Secondary	Effects on menstrual conditions and ovarian function	Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone(AMH)	Prior to treatment begin,and 6 month after single-agent chemotherapy completion, an average of 2 year