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CTRI Number  CTRI/2012/11/003120 [Registered on: 19/11/2012] Trial Registered Prospectively
Last Modified On: 06/11/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two drugs in the treatment of a low risk treatable malignancy 
Scientific Title of Study   Randomised trial of pulsed Actinomycin D versus MTX infusion in low risk gestational trophoblastic neoplasia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anitha Thomas 
Designation  Assistant Professor Grade I 
Affiliation  Christian Medical College, Vellore, India 
Address  Department of Obstetrics and Gynecology Unit I Christian Medical College Vellore-632004

Vellore
TAMIL NADU
632004
India 
Phone  9789683006  
Fax    
Email  anithomas@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Anitha Thomas 
Designation  Assistant Professor Grade I 
Affiliation  Christian Medical College, Vellore, India 
Address  Department of Obstetrics and Gynecology Unit I Christian Medical College Vellore-632004


TAMIL NADU
632004
India 
Phone  9789683006  
Fax    
Email  anithomas@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Anitha Thomas 
Designation  Assistant Professor Grade I 
Affiliation  Christian Medical College, Vellore, India 
Address  Department of Obstetrics and Gynecology Unit I Christian Medical College Vellore-632004


TAMIL NADU
632004
India 
Phone  9789683006  
Fax    
Email  anithomas@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Institutional Fluid research Funding 
 
Primary Sponsor  
Name  Christian Medical College  
Address  Christian Medical College Vellore-632004 Tamil Nadu India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anitha Thomas  Christian Medical College, Vellore  Department of Obstetrics and Gynecology Unit 1 Christain Medical College Vellore, Tamil Nadu, India
Vellore
TAMIL NADU 		 9789683006

anithomas@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Christian Medical College, vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Low risk Gestational Trophoblastic Disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Actinomycin D  Actinomycin-D 1.25 mg/m2 slow IV push and the same repeated every two weeks until the hCG becomes normal 
Intervention  Methotrexate Infusion  MTX 300mg/m² in 500 ml of normal saline given as an IV infusion over six hours followed by folinic acid 15 mg per orally every 6 hours for four doses starting 24 hours after the start of MTX infusion.The same is repeated every two weeks until the hCG becomes normal. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Patients with abnormal hCG regression following any type of pregnancy (molar, term, abortion,ectopic) ie
(1)hCG plateau for 4 consecutive values over 3 weeks
(2)hCG rise of >10% for 3 values over 2 weeks
(3)hCG persistence 6 months after molar pregnancy evacuation

For staging and pretreatment evaluation, all patients will undergo complete physical and pelvic examination, complete blood cell count, urinalysis, liver and renal function tests, and chest x-ray. Ultrasonography and/or computed tomographic scanning will be performed when clinically indicated. Diagnosis, staging, and risk scoring will be as per International Federation of Gynecology and Obstetrics (FIGO) 2000 criteria for diagnosis and staging for GTN.

Low risk gestational trophoblastic disease FIGO score <6 
 
ExclusionCriteria 
Details  •Choriocarcinoma
•Any patient with renal, hepatic,haematological disease
•Pregnancy
•Prognostic score > 6
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary remission rate or Complete response (Proportion)  5years 
 
Secondary Outcome  
Outcome  TimePoints 
Time to cure
Number of cycles required for complete response
Toxicity & Side effects
Cost of treatment

 		 5 years 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   19/11/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   The study will be presented at a scientific meeting and findings will be published in a gyne oncology journal Currently there are none yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Gestational Trophoblastic neoplasia(GTN) is among the rare human malignancies that can be cured even in the presence of widespread metastases. GTN  commonly evolves after a hydatidiform  mole  but could also occur following induced or spontaneous  abortions, ectopic pregnancy or even term pregnancy. Once diagnosed, this disease is staged according to the International Federation of Gynecology and Obstetrics (FIGO) 2000 classification as low and high risk. Low risk GTN( FIGO  Score 6) can be treated with single agent chemotherapy. Actinomycin D(Act-D) and  Methotrexate (MTX) regimens are the most widely used drugs  and have been suggested as the treatment of choice for nonmetastatic/low-risk GTN. Though there are various schedules of Methotrexate  which have  been widely  studied  we chose to compare the Intravenous  Actinomycin D with Intravenous  infusion of Methotrexate .  Our hypothesis is that both these drugs are equally effective in the treatment of this condition. However,  the secondary outcomes such as the number of chemotherapy cycles needed to complete the treatment, time taken to complete treatment,cost of the drugs and  toxicity related adverse events associated with the drugs are different and will help us to decide which one is better. MTX  is planned to be given as 300mg/m² over 6 hours in 500 ml of normal saline followed by administration of folinic acid (FA)  24 hours after the MTX infusion: 15mg per oral Q6H for four doses every two weeks. Act-D will be given as pulse therapy of 1.25 mg/m² IV every two weeks. The chemotherapy schedules will be randomly allocated to either of the two groups after informed consent .The schedules will be repeated every two weeks till the beta hCG becomes normal (Complete response-CR).Two more doses of chemotherapy will be given even after hCG becomes <5 mIU/ml. Patients will then be kept on follow up with clinical examination and hCG estimation every month  till at least 24 months. The effectiveness of these two drugs with respect to differences in remission rates will be evaluated. As both these are equally good, complications, number of cycles of chemotherapy, cost of drugs and recurrence rates  will be evaluated. Those who fail with either of the regimens will be switched over to the other for a further two cycles. If they still don’t respond  to the other drug in the study, then multi agent chemotherapy will be offered. Adverse events will be monitored and patient may be withdrawn from study when deemed necessary due to failiure, toxicity or recurrence.. 
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