Trials / Unknown
UnknownNCT01823315
Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
A Multicenter, Prospective, Randomized Trial of Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Ding Ma · Academic / Other
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Gestational Trophoblastic Disease
- Gestational Trophoblastic Neoplasia
- Gestational Trophoblastic Tumor
- Gestational Trophoblastic Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MTX 1 | MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5 |
| 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 |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2015-12-01
- Completion
- 2019-12-01
- First posted
- 2013-04-04
- Last updated
- 2019-12-24
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01823315. Inclusion in this directory is not an endorsement.