Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
Phase 3
- Conditions
- Gestational Trophoblastic NeoplasiaGestational Trophoblastic TumorGestational Trophoblastic NeoplasmsGestational Trophoblastic Disease
- Interventions
- Registration Number
- NCT01823315
- Lead Sponsor
- Ding Ma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methotrexate Single-coure chemotherapy MTX 1 Regimen: Methotrexate 0.4mg/(kg·d) intramuscularly (IM) on days 1-5. If 10-fold fall of hCG achieved 18 days after treatment completion, success of primary single-course chemotherapy was defined and further treatment was withheld; otherwise, failure was defined and the patient was referred to multi-course chemotherapy. During the period of observation for those with success, if the level of hCG became stationary for at least 3 weeks or rose again, the patient was also referred to multi-course chemotherapy. Additional consolidation chemotherapy with 1-3 courses was given for those who achieved CR by multi-course chemotherapy, but not by single-course regimen. MTX multiple courses chemotherapy MTX 1 Regimen: methotrexate 0.4mg/(kg·d) intramuscularly (IM) on days 1-5, 2-week intervals. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive at least 1 additional consolidation treatment. After treatment, all the patients were asked for contraception with condom or oral contraception. Regular hCG surveillance, once a month for 3 consecutive months and once every 3 months for 2 years, was performed. During follow-up period, pelvic ultrasound and pulmonary X ray or CT scan were conducted if needed. Methotrexate+dactinomycin Single-dose chemotherapy MTX 2 Regimen: dactinomycin d 0.6mg/m2, IV, on day1, 2; methotrexate 100mg/m2, IV, on day1 (after Act-d); methotrexate 200mg/m2, IVgtt, on day1 (after methotrexate, 500ml NS, \>4h). If 10-fold fall of hCG achieved 18 days after treatment completion, success of primary single-course chemotherapy was defined and further treatment was withheld; otherwise, failure was defined and the patient was referred to multi-course chemotherapy. During the period of observation for those with success, if the level of hCG became stationary for at least 3 weeks or rose again, the patient was also referred to multi-course chemotherapy. Additional consolidation chemotherapy with 1-3 courses was given for those who achieved CR by multi-course chemotherapy, but not by single-course regimen. Methotrexate+dactinomycin Single-dose chemotherapy Act-d Regimen: dactinomycin d 0.6mg/m2, IV, on day1, 2; methotrexate 100mg/m2, IV, on day1 (after Act-d); methotrexate 200mg/m2, IVgtt, on day1 (after methotrexate, 500ml NS, \>4h). If 10-fold fall of hCG achieved 18 days after treatment completion, success of primary single-course chemotherapy was defined and further treatment was withheld; otherwise, failure was defined and the patient was referred to multi-course chemotherapy. During the period of observation for those with success, if the level of hCG became stationary for at least 3 weeks or rose again, the patient was also referred to multi-course chemotherapy. Additional consolidation chemotherapy with 1-3 courses was given for those who achieved CR by multi-course chemotherapy, but not by single-course regimen.
- Primary Outcome Measures
Name Time Method Complete response (CR) by single-course through study completion, an average of 1 year Completely remission rate by multiple courses after single-course failure through study completion, an average of 1 year
- Secondary Outcome Measures
Name Time Method the number of courses needed to achieve complete remission after multi-course treatment through study completion, an average of 1 year remission rate of ACTD replacement after MTX resistance through study completion, an average of 1 year complete remission rate by multidrug combination therapy after single drug failure through study completion, an average of 1 year
Trial Locations
- Locations (3)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Qilu Hospital，Shandong University
🇨🇳Jinan, Shandong, China
Women's Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China