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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| Huazhong University of Science and Technology | OTHER |
| Shandong University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate Single-coure chemotherapy | Experimental | 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. |
|
| Methotrexate+dactinomycin Single-dose chemotherapy | Experimental | 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. |
|
| MTX multiple courses chemotherapy | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTX 1 | Drug | MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xing Xie, MD, PhD | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China | ||
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| MTX 2 | Drug | MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, >4h) |
|
| Act-d | Biological | Act-d 0.6mg/m(2), IV, on day1,2 |
|
| complete remission rate by multidrug combination therapy after single drug failure | through study completion, an average of 1 year |
| Qilu Hospital，Shandong University |
| Jinan |
| Shandong |
| 250012 |
| China |
| Women's Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310006 | China |
| ID | Term |
|---|---|
| D031901 | Gestational Trophoblastic Disease |
| ID | Term |
|---|---|
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003609 | Dactinomycin |
| ID | Term |
|---|---|
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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