Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Primary Surgery Plus Single Course Methotrexate Versus Primary Methotrexate for Treatment of Gestational Trophoblastic Neoplasms in Low Risk Cases Above 40y: a Randomized Controled Trial

Conditions
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Gestational Trophoblastic Neoplasms

Intervention / Treatment
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* Procedure: Total abdominal hysterectomy and methotrexate
* Drug: Methotrexate plus folinic acid alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery and methotrxate<br>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 | Procedure: Total abdominal hysterectomy and methotrexate<br>* 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)<br>* Other names: surgery and chemotherapy;|
| Active Comparator: methotrxate<br>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 | Drug: Methotrexate plus folinic acid alone<br>* 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<br>* Other names: chemotharapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML |  | 1-6 months | 

Secondary Outcome Measures

| Outcome Measure | 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, | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hystrectomy, gestaional trophoblastic neoplasm, chemotherapy, methotrxate