Clinical trial NCT04562558: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective，multicenter，randomized trial with two arms
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Completely remission (CR) rate by single-agent
timeFrame: 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
measure: Overall completely remission rate
timeFrame: 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 outcomes:
measure: The duration needed to achieve complete remission after single-agent chemotherapy
timeFrame: 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
measure: The number of courses needed to achieve complete remission after single-agent chemotherapy
timeFrame: 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
measure: Incidence of Adverse Effects (Grade 3 or Higher)
timeFrame: through study completion, an average of 3 year
measure: Effects on menstrual conditions and ovarian function
timeFrame: Prior to treatment begin，and 6 month after single-agent chemotherapy completion, an average of 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
name: yang xiang
role: STUDY_DIRECTOR
References: