Gestational Trophoblastic Neoplasms
Conditions
Keywords
gestaional trophoblastic neoplasm, hystrectomy, chemotherapy, methotrxate
Brief summary
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially methotrexate and the investigators try to find a role of surgery plus methotrexate instead of multiple doses and cycles of chemotherapy.
Detailed description
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy espechialy methotrexate and the investigators try to find a role of surgery plus mehotrexate instead of multiple doses and cycles of chemotherapy that affect the patient quality of life and complication related to both line of management and time of decrease of B-hcg.
Interventions
PROCEDURETotal abdominal hysterectomy and methotrexate
After written consent laparotomy will be done then pelvic examination for extra uterine spread, palpation of liver, omentum for any gross lesions and then hystrectomt bilateral salpigooophrectomy will be done) plus single course methotrexate(anti folate chemotheraputic agent, vial form given by intramuscular injection) 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG (the cycle may be repeated until normalization of B-HCG)
DRUGMethotrexate plus folinic acid alone
methotrxate 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG and cycle repeated until normalization of B-HCG
Sponsors
Maher elesawi kamel elesawi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* females * 40 years or more * plateau or rising B- hCG titre * without distant metastasis * WHO score is less than 7
Exclusion criteria
* less than 40 years * distant metastasis to lung and liver * chronic medical diseases * WHO score is more than 7
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML | 1-6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life( questionairre) | 1-6 months | pain scale from zero to 11, return to ordinary activities |
| complications from management | 1-6 months | renal, hepatic impairments, anemia, |
| time interval for B-hCG reach less than 5 MU/ML | 1-6 months | the time taken for B-hCG to reach below 5 MU/ML |
Countries
Egypt
Contacts
Primary Contactmaher elesawi, Msc
Outcome results
None listed