Back to resultsBiweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia
Primary Purpose
Gestational Trophoblastic Tumor, Gestational Trophoblastic Neoplasia, Stage I Gestational Trophoblastic Tumor
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Methotrexate
Leucovorin
Dactinomycin
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Trophoblastic Tumor focused on measuring gestational trophoblastic neoplasia, actinomycin-D, methotrexate, low-risk
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm1-Methotrexate
Arm 2-Dactinomycin
Arm Description
Patients receive methotrexate intramuscularly（50mg） on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment. If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.
Patients will receive IV pulse actinomycin-D (1.25mg/m2，2mg max dos) every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment.If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
The duration needed to achieve complete remission after single-agent chemotherapy
The duration needed to achieve complete remission after single-agent in two arms
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
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
Effects on menstrual conditions and ovarian function
Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone（AMH）
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04562558
Brief Title
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
xiang yang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Trophoblastic Tumor, Gestational Trophoblastic Neoplasia, Stage I Gestational Trophoblastic Tumor, Stage II Gestational Trophoblastic Tumor, Stage III Gestational Trophoblastic Tumor, Invasive Mole, Choriocarcinoma
Keywords
gestational trophoblastic neoplasia, actinomycin-D, methotrexate, low-risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective，multicenter，randomized trial with two arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm1-Methotrexate
Arm Type
Experimental
Arm Description
Patients receive methotrexate intramuscularly（50mg） on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment. If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.
Arm Title
Arm 2-Dactinomycin
Arm Type
Experimental
Arm Description
Patients will receive IV pulse actinomycin-D (1.25mg/m2，2mg max dos) every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment.If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MTX
Intervention Description
50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Calcium folinate
Intervention Description
15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days
Intervention Type
Drug
Intervention Name(s)
Dactinomycin
Other Intervention Name(s)
dactinomycin D
Intervention Description
1.25mg/m2 (2mg max dose)intravenous every 14 days.
Primary Outcome Measure Information:
Title
Completely remission (CR) rate by single-agent
Description
Percentage of participants with complete response by single-agent chemotherapy. A complete response was defined as a normal hCG sustained over 3 weekly measurements.
Time Frame
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
Title
Overall completely remission rate
Description
Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure
Time Frame
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 Outcome Measure Information:
Title
The duration needed to achieve complete remission after single-agent chemotherapy
Description
The duration needed to achieve complete remission after single-agent in two arms
Time Frame
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
Title
The number of courses needed to achieve complete remission after single-agent chemotherapy
Description
The number of courses needed to achieve complete remission after single-agent chemotherapy in two arms
Time Frame
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
Title
Incidence of Adverse Effects (Grade 3 or Higher)
Description
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
Time Frame
through study completion, an average of 3 year
Title
Effects on menstrual conditions and ovarian function
Description
Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone（AMH）
Time Frame
Prior to treatment begin，and 6 month after single-agent chemotherapy completion, an average of 2 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Xiang
Phone
86-010-69155635
Email
xiangy@Pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yang xiang
Organizational Affiliation
Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Xiang
Phone
01069156068
Email
XiangY@pumch.cn
12. IPD Sharing Statement
Learn more about this trial
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia
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