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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery and methotrxate | Active Comparator | The patient will be treated by total abdominal hystrectomy(after written consent laparatomy 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 alternating with calcium folinate 0.1 mg/kg until normalization of B-HCG |
|
| methotrxate | Active Comparator | The patient will be treated by multiple courses of methotrexate( antifolate) 1mg/kg every 14 days each one alternating in every otherday with calcium folinate 0.1 mg/kg till normalization of B-HCG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total abdominal hysterectomy and methotrexate | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML | 1-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life( questionairre) | pain scale from zero to 11, return to ordinary activities | 1-6 months |
| complications from management | renal, hepatic impairments, anemia, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| maher elesawi, Msc | Contact | 01016103662 | maherelesawi@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Reda hemida, MD | Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospital | Recruiting | Al Mansurah | Dakahlia Governorate | Egypt |
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| Methotrexate plus folinic acid alone | Drug | 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 |
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| 1-6 months |
| time interval for B-hCG reach less than 5 MU/ML | the time taken for B-hCG to reach below 5 MU/ML | 1-6 months |
| Maher Elesawi Kamel Elesawi | Recruiting | Mīt Ghamr | Eldakahlia | Egypt |
|
| ID | Term |
|---|---|
| D031901 | Gestational Trophoblastic Disease |
| ID | Term |
|---|---|
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D013514 | Surgical Procedures, Operative |
| D004358 | Drug Therapy |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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