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

Phase 2

• Conditions: Gestational Trophoblastic Neoplasms
• Interventions: Procedure: Total abdominal hysterectomy and methotrexate; Drug: Methotrexate plus folinic acid alone

• Registration Number: NCT02606539
• Lead Sponsor: Maher elesawi kamel elesawi

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.

Study Timeline

• Study First Submitted: 2015-08-08
• Study Start: 2015-09
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-17
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22
• Primary Completion: 2017-06
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery and methotrxate	Total abdominal hysterectomy and methotrexate	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	Methotrexate plus folinic acid alone	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

Primary Outcome Measures

Name	Time	Method
number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML	1-6 months

Secondary Outcome Measures

Name	Time	Method
complications from management	1-6 months	renal, hepatic impairments, anemia,
quality of life( questionairre)	1-6 months	pain scale from zero to 11, return to ordinary activities
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

Trial Locations

Locations (2)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt

Maher Elesawi Kamel Elesawi; 🇪🇬 Mit Ghamr, Eldakahlia, Egypt