Comparison of pulsed Actinomycin versus 5-day Methotrexate for the treatment of low-risk gestational trophoblastic disease

Comparison of pulsed Actinomycin versus 5-day Methotrexate for the treatment of low-risk gestational trophoblastic disease in patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015012519567N1

Enrollment

Registered

2015-02-05

Start date

2011-03-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

low risk gestational trophoblastic neoplasm. Malignant neoplasms of female genital organs

Interventions

Intervention 1: Intervention group 1:Actinomycin pulse protocol(1.25 miligram per square meter)every 14 days intra vascular (maximum dose 2 miligram). Intervention 2: Intervention group2 :methotrexate

Treatment - Drugs

Intervention group 1:Actinomycin pulse protocol(1.25 miligram per square meter)every 14 days intra vascular (maximum dose 2 miligram)

Intervention group2 :methotrexate protocol (4 miligram perkilogram)every 14 days intravascular (maximum dose25 miligram)

Eligibility

Sex/Gender

Female

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
BetaHCG test. Timepoint: every 2 weeks. Method of measurement: Assay Kit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereshteh Abbaslou

Faculty of medicine,Tehran university

fabbaslou@yahoo.com+98 21 8890 0002

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026