Comparison of pulsed Actinomycin versus 5-day Methotrexate for the treatment of low-risk gestational trophoblastic disease
- Conditions
- low risk gestational trophoblastic neoplasm.Malignant neoplasms of female genital organs
- Registration Number
- IRCT2015012519567N1
- Lead Sponsor
- Vice Chancellor for research of Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 44
Postmolar Gestational trophoblastic neoplasm who meet FIGO stage 1,2,3criteria.
Patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria :
Less than 10% decrease in the ßHCG level using as a reference the first value in the series of 4 values taken over a period of 3weeks ;
More than 20% sustained rise in the ßHCG taking as a reference the first value in The series of 3 values taken over a period of 2weeks (more than50 );
Persistently elevated ßHCG level a period of 6 months (more than50 );
W.H.O. risk score 0-6;
Patients must have normal hepatic, hematologic, and renal function
Exclusion criteria:
Patients who do not have GTN as defined Criteria;
Patients who have previously been treated with cytotoxic chemotherapy. However, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study;
Patients with placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT);
Patients who wish to breast-feed during treatment;
Patients with non-gestational choriocarcinoma;
Disease progression;
Pregnancy.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BetaHCG test. Timepoint: every 2 weeks. Method of measurement: Assay Kit.
- Secondary Outcome Measures
Name Time Method