Introduction: A molar pregnancy is a gestational trophoblastic diseases that grows into a mass in the uterus that has swollen chorionic villi. These villi grow in clusters that resemble grapes.This study is designed to avaluate success comparison between, EMA-CO and EMA-CE chemotherapy in treating Gentational Trophoblastic Neoplasms.
Methods: 50 patients, willing to enter the study, suffering from trophoblastic diseases which did not respond enough to one-drug therapy wich Mole Stage 1 or 2, or Mole Score more than 7 were enrolled. The patients were randomly allocated into 2 equal groups: 1- EMA-CO standard treatment group and 2- EMA-CE standard treatment group. Beta-HCG was evaluated 12 hours after the last dose of chemotherapy. AST, ALT, BNU, and creatinine were evaluated time by time foe excluding patinets with renal or liver failure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311309656N2
Registration date:2013-12-11, 1392/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-11, 1392/09/20
Registrant information
Name
Soheila Aminimoghaddam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2280 5193
Email address
s-aminimoghadam@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Standard EMA-CO and EMA-CE chemotherapy in treating Gentational Trophoblastic Neoplasms
Public title
Comparison of 2 different treatment in Molar Pregnanc
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all Pregnant Patients which did not respond enough to one-drug therapy; Mole Stage 1 or 2 , or Mole Score more than 7; no disorder in liver, renal or genital biochemical tests; no other neoplasmic disorder and willing to enter the study.
Exclusion criteria: any signs of Renal or Liver Failure during the study; willing to go out of the study at any stage.
Age
From 18 years old to 45 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Poursina St.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
909
Health conditions studied
1
Description of health condition studied
Gestational trophoblastic disease
ICD-10 code
O01
ICD-10 code description
Gestational trophoblastic disease
2
Description of health condition studied
Choriocarcinoma
ICD-10 code
D39.2
ICD-10 code description
Chorioadenoma destruens
Primary outcomes
1
Description
Beta-HCG levels
Timepoint
12 hours after last chemotherapy dose
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
EMA – CE =etoposide 100 mg/m2, methotrexate 300 mg/m2 and actinomycin D 0.5 mg on day 1 and 2 and Cisplatin 600 mg/m2, andetoposide 100 mg/m2 on days 8, were administered intravenously every 3 weeks
Category
Treatment - Drugs
2
Description
EMA – CO= etoposide 100 mg/m2, methotrexate 300 mg/m2 and actinomycin D 0.5 mg on day 1 and 2 and cyclophosphamide 600 mg/m2, and vincristine 1 mg/m2 (maximum dose of 2 mg) on days 8, were administered intravenously every 3 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Soheila Aminimoghaddam
Street address
OB-GYN ward, Firoozgar Hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Mirza Kouchak Khan Womens Hospital
Full name of responsible person
Soheila Aminimoghaddam
Street address
OB-GYN ward, Firoozgar Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
Poursina St., 16 Azar Ave., Keshavarz Bulv.
City
Tehran
Grant name
پایان نامه دستیار تخصصی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheila Aminimoghaddam
Position
Assistant Professor, OB-GYN specialist
Other areas of specialty/work
Street address
Firoozgar Hospital, Behafarin St. Hafiz Ave.
City
Tehran
Postal code
Phone
+98 21 2280 5193
Fax
Email
dr_aminimoghaddam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Soheila Aminimoghaddam
Position
Assitant Professor, OB-GYN specialist
Other areas of specialty/work
Street address
Firoozgar Hospital, Behafarin St., Hafiz Ave.
City
Tehran
Postal code
Phone
+98 21 2280 5193
Fax
Email
dr_aminimoghaddam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
OB-GYN ward, Firoozgar Hospital
Full name of responsible person
Soheila Aminimoghaddam
Position
Assistant Professor, Ob-GYN specialist
Other areas of specialty/work
Street address
Beh afarin St., Hafiz Bulv
City
Tehran
Postal code
Phone
+98 21 2280 5193
Fax
Email
dr_aminimoghaddam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)