The aim of this study is to compare the efficacy of Methotrexate and Actinomycin D as single agents in first-line chemotherapy for women with low-risk gestational trophoblastic neoplasia.
A total of 30 women with low-risk gestational trophoblastic neoplasia were randomized to receive a weekly pulsed dose of 40 mg per square meter of body surface of Methotrexate intramuscularly or a pulsed intravenous bolus of 1.25 mg per square meter of body surface of Actinomycin D every 2 weeks . Beta hCG of serum was checked weekly. An additional cycle was administered to both groups as consolidation treatment following normalization of the serum level of beta-human chorionic gonadotropin (less than 10 International Unit per Liter).Duration and number of cycles of chemotherapy and incidence of complication were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012062810128N1
Registration date:2012-08-31, 1391/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-31, 1391/06/10
Registrant information
Name
Shima Razi
Name of organization / entity
Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1338 0820
Email address
razi-sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapur University of Medical Science
Expected recruitment start date
2009-10-01, 1388/07/09
Expected recruitment end date
2011-10-01, 1390/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Actinomycin D and Methotrexate effectiveness in treatment of Gestational Trophoblastic Neoplasia based on bhCG level
Public title
Comparison of Actinomycin D and Methotrexate in treatment of Mole Hydatiform
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All patient in OB/GYN clinic of Emam khomeiny hospital of ahwaz during 2008 to 2010 suffering low risk gestattional trophoblastic neoplasia
exclusion criteria: History of chemotherapy(except for non melanotic skin cancer); History of chemotherapy due to GTN; History of malignancy with less than 5 years disease free; Patient with affected function of liver or kidney
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapur University of Medical Science
Street address
Jundishapur University of Medical Science, Golestan Ave, Ahwaz, Khuzestan, Iran
City
Ahwaz
Postal code
Approval date
2009-09-23, 1388/07/01
Ethics committee reference number
د/527
Health conditions studied
1
Description of health condition studied
Gestational Trophoblastic Neoplasia
ICD-10 code
O01.9
ICD-10 code description
Mole Hydatiform,Nonspecific Trophoblastic Disease NOS
Primary outcomes
1
Description
beta hCG
Timepoint
weekly
Method of measurement
mIu/ml
Secondary outcomes
1
Description
liver enzyme elevation
Timepoint
weekly
Method of measurement
mIU/ml
Intervention groups
1
Description
Control group: weekly pulsed dose of 40 mg/m(2) of methotrexate intramuscularly
Category
Treatment - Drugs
2
Description
Intervention group:pulsed intravenous bolus of 1.25 mg per square meter of body surface of Actinomycin D every 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeiny Hospital Ahwaz
Full name of responsible person
Dr.Shima Razi
Street address
Clinic of Gynecologic Oncology of Emam Khomeiny Hospital, Azadegan Ave, Ahwaz, Khuzestan, Iran,
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapur Medical Science University Branch of Research
Full name of responsible person
Dr Mostafa Feghhi MD
Street address
Jundishapur Medical Science University Branch of Research, Golestan Ave, Ahwaz, Khuzestan, Iran
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapur Medical Science University Branch of Research
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
Jundi Shapur Medical Science University
Full name of responsible person
Shima Razi
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Jundi Shapur Medical Science University, Golestan Ave, Ahwaz, Khuzestan, Iran
City
Ahwaz
Postal code
Phone
+98 61 1333 7681
Fax
+98 61 1292 1835
Email
razi-sh@ajums.ac.ir
Web page address
www.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundi Shapur Medical Science University of Ahwaz
Full name of responsible person
Shima Razi
Position
Resident of Gynecology/MD
Other areas of specialty/work
Street address
School of medicine branch of research, Jundi Shapur Medical Science University of Ahwaz, Golestan Ave, Ahwaz, Khuzestan, Iran
City
Ahwaz
Postal code
Phone
+98 61 1333 7681
Fax
+98 61 1292 9835
Email
razi-sh@ajums.ac.ir
Web page address
www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jundi Shapur Medical Science University
Full name of responsible person
Shiama Rrazi
Position
MD/Resident of Gynecology
Other areas of specialty/work
Street address
Jundishapur Medical Science University, Golestan Ave, Ahwaz, Khuzestan, Iran
City
Ahwaz
Postal code
Phone
+98 61 1333 7681
Fax
+98 61 1292 0835
Email
razi-sh@ajums.ac.ir
Web page address
www.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)