Short versus long chemotherapy regiment for trophoblastic tumor

A phase III randomized trial of multi-day methotrexate versus biweekly pulse of methotrexate and actinomycin for the treatment of low-risk gestational trophoblastic neoplasia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74959523

Enrollment

120

Registered

2018-04-24

Start date

2018-01-29

Completion date

Unknown

Last updated

2018-05-28

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

Conditions

Gestational trophoblastic neoplasia (GTN) Pregnancy and Childbirth Gestational trophoblastic neoplasia (GTN)

Interventions

Block randomization was done online at the site: https://www.sealedenvelope.com/simple-randomiser/v1/lists. Experimental arm: Patients receive methotrexate 200 mg/m2 IV in 500 ml NS over 12 hours pl

cycle repeats every 2 weeks. Active comparator arm: Patients receive methotrexate 50mg/m2 IM on days 1, 3, 5, and 7 and folinic acid 5 mg IV on days 2, 4, 6, and 8

cycle repeats every 2 weeks. Follow-up will be at each 2-weekly cycle of chemotherapy, with 3-4 months required to complete the treatment cycle. Patients will be followed up for at least 1 year as per

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically proven post molar GTN (Persistent mole for =4 months) or choriocarcinoma 2. Female 3. Age 18 years or above 4. WHO risk score of 6 or less 5. Willing to practice effective contraception for the duration of the study 6. Consented for participation

Exclusion criteria

Exclusion criteria: 1. Lactating 2. PSTT, non-gestational neoplasia 3. Abnormal CBC, LFT,RFT 4. Cancers in other organs

Design outcomes

Primary

Measure	Time frame
Time to achieve serum ß-hCG <5 mU/ml measured using the blood test at clinical laboratory of study site as a routine practice in the hospital prior to recruitment and then every 2 weeks before commencing each subsequent chemotherapy cycle until the level comes down to normal for two timepoints.	—

Secondary

Measure	Time frame
1. Total hospital admission days is measured using source document from treatment and discharge date. 2. Compliance to complete therapy is measured using defined follow up dates and rate of defaulter. 3. Need of high-risk regimen is measured by switch over into high-risk treatment regimen (if any). 4. Need of surgical intervention is measured using type of treatment received in each visit cycle.	—

Countries

Nepal

Outcome results

None listed

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