GTN-01: Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Methotrexate Single-coure chemotherapy 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. |
Drug: MTX 1
MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5
|
Experimental: Methotrexate+dactinomycin Single-dose chemotherapy 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. |
Drug: MTX 2
MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, >4h)
Biological: Act-d
Act-d 0.6mg/m(2), IV, on day1,2
|
Active Comparator: MTX multiple courses chemotherapy 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. |
Drug: MTX 1
MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5
|
Outcome Measures
Primary Outcome Measures
- 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
- remission rate of ACTD replacement after MTX resistance [through study completion, an average of 1 year]
- the number of courses needed to achieve complete remission after multi-course treatment [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who FIGO Stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN);
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WHO risk score 0-6;
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Age≤60 years; female, Chinese women;
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Initial treatment is chemotherapy; patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study;
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Performance status: Karnofsky score≥60;
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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
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Provide written informed consent.
Exclusion Criteria:
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Patients with unconfirmed diagnosis of GTN;
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Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
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WHO risk score >6;
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With severe or uncontrolled internal disease, unable to receive chemotherapy;
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Concurrently participating in other clinical trials
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Unable or unwilling to sign informed consents;
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Unable or unwilling to abide by protocol.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430030 |
2 | Qilu Hospital,Shandong University | Jinan | Shandong | China | 250012 |
3 | Women's Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310006 |
Sponsors and Collaborators
- Ding Ma
- Zhejiang University
- Huazhong University of Science and Technology
- Shandong University
Investigators
- Study Chair: Xing Xie, MD, PhD, Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2012-GYN/GTN-01