Comparison of two drugs in the treatment of a low risk treatable malignancy

Phase 3

Recruiting

Conditions: Low risk Gestational Trophoblastic Disease

Registration Number: CTRI/2012/11/003120

Lead Sponsor: Christian Medical College

Brief Summary: Gestational Trophoblastic neoplasia(GTN) is among the rare humanmalignancies that can be cured even in the presence of widespread metastases. GTN commonly evolves after a hydatidiform mole but could also occur following induced orspontaneous abortions, ectopic pregnancyor even term pregnancy. Once diagnosed, this disease is staged according to the InternationalFederation of Gynecology and Obstetrics (FIGO) 2000classification aslow 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 mostwidely used drugs and have beensuggested as the treatment of choice for nonmetastatic/low-risk GTN. Though there are variousschedules of Methotrexate whichhave been widely studied we chose to compare the Intravenous Actinomycin D with Intravenous infusion of Methotrexate . Our hypothesis is that both these drugs are equallyeffective in the treatment of this condition. However, the secondary outcomes such as the number ofchemotherapy cycles needed to complete the treatment, time taken to completetreatment,cost of the drugs and toxicityrelated adverse events associated with the drugs are different and will help usto decide which one is better. MTX isplanned to be given as 300mg/mÂ² over 6 hours in 500 ml of normal salinefollowed by administration of folinic acid (FA) 24 hours after the MTX infusion: 15mg per oral Q6H for four doses everytwo weeks. Act-D will be given as pulse therapy of 1.25 mg/mÂ² IV every twoweeks. The chemotherapy schedules will be randomly allocated to either of the twogroups after informed consent .The schedules will be repeated every two weekstill the beta hCG becomes normal (Complete response-CR).Two more doses ofchemotherapy will be given even after hCG becomes <5 mIU/ml. Patients willthen be kept on follow up with clinical examination and hCG estimation everymonth till at least 24 months. The effectivenessof these two drugs with respect to differences in remission rates will beevaluated. As both these are equally good, complications, number of cycles ofchemotherapy, cost of drugs and recurrence rates will be evaluated. Those who fail with eitherof the regimens will be switched over to the other for a further two cycles. Ifthey still donâ€™t respond to the otherdrug in the study, then multi agent chemotherapy will be offered. Adverseevents will be monitored and patient may be withdrawn from study when deemednecessary due to failiure, toxicity or recurrence..

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 150

Inclusion Criteria

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.

Exclusion Criteria

â€¢Choriocarcinoma â€¢Any patient with renal, hepatic,haematological disease â€¢Pregnancy â€¢Prognostic score > 6.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary remission rate or Complete response (Proportion)	5years

Secondary Outcome Measures

Name	Time	Method
Time to cure	Number of cycles required for complete response

Trial Locations

Locations (1): Christian Medical College, Vellore
🇮🇳
Vellore, TAMIL NADU, India
Christian Medical College, Vellore
🇮🇳Vellore, TAMIL NADU, India
Dr Anitha Thomas
Principal investigator
9789683006
anithomas@cmcvellore.ac.in