Choriocarcinoma, Gestational Trophoblastic Neoplasia, Gestational Trophoblastic Tumor, Invasive Mole, Stage I Gestational Trophoblastic Tumor, Stage II Gestational Trophoblastic Tumor, Stage III Gestational Trophoblastic Tumor
Conditions
Keywords
gestational trophoblastic neoplasia, actinomycin-D, methotrexate, low-risk
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.
Interventions
DRUGMethotrexate
50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days
DRUGLeucovorin
15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days
DRUGDactinomycin
1.25mg/m2 (2mg max dose)intravenous every 14 days.
Sponsors
xiang yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective，multicenter，randomized trial with two arms
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completely remission (CR) rate by single-agent | 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 | 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 | 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 | Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration needed to achieve complete remission after single-agent chemotherapy | 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 | 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 | 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 | The number of courses needed to achieve complete remission after single-agent chemotherapy in two arms |
| Incidence of Adverse Effects (Grade 3 or Higher) | through study completion, an average of 3 year | 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 | Prior to treatment begin，and 6 month after single-agent chemotherapy completion, an average of 2 year | Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone（AMH） |
Countries
China
Outcome results
None listed