|- candidate number||11315|
|- NTR Number||NTR3390|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mrt-2012|
|- Secondary IDs||R /48 Mansoura University Hospital, Egypt |
|- Public Title||The impact of uterine re-curettage on the number of chemotherapy courses in treatment of post molar gestational trophoblastic neoplasia. A randomized – controlled study.|
|- Scientific Title||The impact of uterine re-curettage on the number of chemotherapy courses in treatment of post molar gestational trophoblastic neoplasia. A randomized – controlled study.|
|- hypothesis||A vaccumcurettage in persistent trophoblactic disease decreases the number of chemotherapy cycles needed to obtain normalisation of the hCG level.|
|- Healt Condition(s) or Problem(s) studied||Chemotherapy, Curretage, Persistent trophoblastic disease, Molar pregnancy|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||6-dec-2011|
|- planned closingdate||31-dec-2013|
|- Target number of participants||80|
|- 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. hCG will be checked and each subsequent course will start on day 14. After normalisation of the hCG level two consolidation courses will be given.
In the study arm patients treatment will start with uterine re-curettage, immediately followed by the above described chemotherapy regiment.
Treatment duration depends on the hCG regression; 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 line therapy (Actinomycin-D or MAC) will be individualized according to the tumour board recommendations.
The number of chemotherapy cycles needed to reach normalization of hCG levels will be the primary endpoint in the study.
|- Primary outcome||The number of chemotherapy courses needed to reach complete response.|
|- Secondary outcome||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.
|- Timepoints||Complete response is the moment when B-hCG level is below the pregnant level or zero.|
A year after completing treatment relapse rate, duration of treatment, and hysterectomy will be evaluated.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| H.C. Doorn, van|
|- CONTACT for SCIENTIFIC QUERIES|| H.C. Doorn, van|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Department of Obstetrics and Gynaecology, Mansoura University Hospital, Egypt|
|- Publications||Reda A Hemida, EmanToson, H.C. Van Doorn.The impact of uterine re-curettage, pre-evacuation and week-one level of hCG on the number of chemotherapy courses in treatment of post molar GTN. Journal of Excremental Ther and Oncol., Vol 9. P 217-230.|
|- Brief summary||Background:|
Post molar GTD was reported to occur in 7.5-20% of patients following evacuation of complete hydatidiform moles and in 2.5-7.5% following evacuation of partial moles. The role of uterine re-curettage in post molar GTD is not clear.
Study of the effect of uterine re-curettage on the number of chemotherapy courses in treatment of post molar GTD.
Patients and methods:
A prospective randomized study will be conducted in the department of Gynaecology and Obstetrics, Mansoura University Hospital, Egypt. It will include at least 80 cases of post molar GTD. The patient will be randomized into 2 arms; the control arm will receive chemotherapy without re-curettage, the study arm consist of uterine re-curettage followed by chemotherapy. The primary endpoint will be the number of chemotherapy courses till complete response.
Uterine re-curettage in gestational trophoblastic disease.
The trial is conducted at the Mansoura University Hospital, Egypt in close collaboratio with the ErasmusMC, Daniel den Hoed clinic.
|- Main changes (audit trail)|
|- RECORD||12-mrt-2012 - 21-apr-2012|