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

Gestational Trophoblastic Neoplasms Clinical Trial

— SVCGTN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02606539
• Other study ID #: GTN and surgery
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 8, 2015
• Last updated: March 21, 2017
• Start date: September 2015
• Est. completion date: August 2017

Study information

• Verified date: November 2015
• Source: Mansoura University
• Contact: maher elesawi, Msc
• Phone: 01016103662
• Email: maherelesawi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Neoplasms
• Neoplasms
• Trophoblastic Neoplasms

Intervention

Procedure:
• Total 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)

Drug:
• Methotrexate 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

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Dakahlia
Egypt	Maher Elesawi Kamel Elesawi	Mit Ghamr	Eldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Maher elesawi kamel elesawi

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML		1-6 months
Secondary	quality of life( questionairre)	pain scale from zero to 11, return to ordinary activities	1-6 months
Secondary	complications from management	renal, hepatic impairments, anemia,	1-6 months
Secondary	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