Hydatidiform mole. Complete hydatidiform mole ,Incomplete and partial hydatidiform mole ,Chorioadenoma destruens ,Hydatidiform mole: • invasive • malignant
Conditions
Interventions
Intervention 1: Intervention group: pulsed intravenous bolus of 1.25 mg/m2 of ACT-D every 2 weeks. Intervention 2: Control group: intramuscular MTX 1 mg/kg per day on days 1, 3, 5 and 7 alternatively
Treatment - Drugs
Intervention group: pulsed intravenous bolus of 1.25 mg/m2 of ACT-D every 2 weeks
Control group: intramuscular MTX 1 mg/kg per day on days 1, 3, 5 and 7 alternatively with intramuscular folinic acid 0.1 mg/kg per day on days 2, 4, 6 and 8 for only one course
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion criteria: having a plateau or rising of serum Beta human chorionic gonadotropin (B-hCG) level or persistent elevation above the normal B-hCG value 16 weeks after molar (complete or incomplete) evacuation after previous molar (complete or incomplete) pregnancy. Plateau B-hCG level is defined as 10% or lesser change in B-hCG titer at least over 3 weeks (4 values in days 1, 7, 14, 21) and rising B-hCG titer is defined as greater than 10% increase in B-hCG titer at least over 2 weeks (3 values in days 1, 7, 14) . Eligible patients will be untreated low risk GTN (LRGTN) whose stage is I and score by the modified world health organization (WHO) prognostic scoring system adopted by FIGO is 6 or less. Exclusion criteria: histologically confirmed choriocarcinoma or placental site trophoblastic tumor (PSTT), not agree to have effective contraception for the duration of the study, metastasis, FIGO prognostic score of 7 or more, willing to continue breast feeding, presence of other malignancies with disease free duration less than 5 year, contraindication for protocols of chemotherapy due to previous cancer treatment, prior chemotherapy or hysterectomy for GTN
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response. Timepoint: before intervention and weekly after intervention. Method of measurement: B-hCG serum measurement by radioimmunoassay, Serum B-hCG level less than 5 miu/ml. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects. Timepoint: before intervention, then in the ACT-D group : weekly. in the MTX-FA group : on days 1, 3, 5 and 7 of treatment. Method of measurement: hematologic, hepatic, renal, dermatologic and gasterointestinal (nausea, vomiting, diarrhea and stomatitis) which are graded based on the World Health Organization (WHO) as grade 3 or 4 toxicity. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehrzad Sadagiani
Tabriz University of Medical Sciences
Outcome results
None listed