Clinical trial NCT01823315: Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gestational Trophoblastic Disease
Gestational Trophoblastic Neoplasia
Gestational Trophoblastic Tumor
Gestational Trophoblastic Neoplasms
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: Huazhong University of Science and Technology
name: Shandong University
First posted: 2013-04-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Complete response (CR) by single-course
timeFrame: through study completion, an average of 1 year
measure: Completely remission rate by multiple courses after single-course failure
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: remission rate of ACTD replacement after MTX resistance
timeFrame: through study completion, an average of 1 year
measure: the number of courses needed to achieve complete remission after multi-course treatment
timeFrame: through study completion, an average of 1 year
measure: complete remission rate by multidrug combination therapy after single drug failure
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Jinan
country: China
facility: Qilu Hospital，Shandong University
state: Shandong
city: Hangzhou
country: China
facility: Women's Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Xing Xie, MD, PhD
role: STUDY_CHAIR
References: