The impact of uterine re-curettage on the number of chemotherapy courses in treatment of post molar gestational trophoblastic neoplasia. A randomized – controlled study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23724

Enrollment

Registered

2012-03-12

Start date

2011-12-06

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Persistent trophoblastic disease, molar pregnancy, chemotherapy, curettage. Persisterende trofoblast, mola zwangerschap, chemotherapie, curettage

Interventions

The standard arm will receive intramuscular methotrexate (MTX) as first-line treatment in a dose of 1 mg/kg on days 1, 3, 5, 7 alternating with oral folinic acid in a dose of 15 mg in days 2, 4, 6, 8.

for all patients 2 consolidation courses are given after normalisation of hCG levels. Patients whose hCG levels plateau or rise will be changed to second line chemotherapy. The choice of second lin

Eligibility

Inclusion criteria

Inclusion criteria: 1. Non metastatic post molar GTD cases who will be diagnosed after: A. Persistent positive hCG more than 6 months after evacuation of molar pregnancy; B. Plateuing serum level of hCG after evacuation of molar pregnancy; C. Rising serum level of hCG after evacuation of molar pregnancy. 2. Low and intermediate risk PTD: (WHO score <8); 3. WHO performance status 0-2; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Post molar GTD with distant metastasis; 2. History of uterine perforation; 3. Patients refusing randomization; 4. High risk PTD (WHO score > 7); 5. Histological diagnosis of choriocarcinoma, invasive mole, or placental site trophoblastic tumour (PSTT); 6. hCG level > 5.000 IU.

Design outcomes

Primary

Measure	Time frame
The number of chemotherapy courses needed to reach complete response.	—

Secondary

Measure	Time frame
1. Response rate; 2. Rate of relapse of GTD in both groups; 3. Duration of treatment; 4. The need for hysterectomy; 5. Complications of uterine re-curettage in group A; 6. Number of cycles in relation to histopathological findings.	—

Contacts

Public ContactH.C. Doorn, van

Erasmus MC Daniel den Hoed kliniek

h.vandoorn@erasmusmc.nl+31 (0)10 7041263

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)