- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01984099
RCT on the Efficacy of Methotrexate for the Prevention of GTD
The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole.
Women who will undergo suction curettage for complete hydatidiform mole at the Philippine General Hospital, who are at risk for developing postmolar gestational trophoblastic disease will be included in the study. Patients will receive either a single course of methotrexate or vitamin B complex (Benutrex) within fourteen days from molar evacuation. Patients' serum beta HCG will be monitored 1 week after molar evacuation and then every 2 weeks until the titers become normal for three consecutive determinations, then monthly for 6 months (every 2 months for the next 6 months).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Manila
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Taft Avenue, Ermita, Manila, Manila, Philippines, 1000
- Philippine General Hospital, University of the Philippines Manila
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis and molar evacuation done at the Department of Obstetrics and Gynecology of the Philippine General Hospital;
- patients who will undergo suction curettage for evacuation of molar pregnancy;
- histopathologically confirmed complete hydatidiform mole;
must have at least one of the following risk factors for the development of postmolar gestational trophoblastic disease:
- uterine size larger than age of gestation of more than 6 weeks
- serum B-hCG titer more than or equal to 100,000 mlU/ml
- theca lutein cysts more than or equal to 6 cms in size
- gravidity of 4 or more
- recurrent molar pregnancy
- medical complications arising from trophoblastic proliferation such as DIC, pre-eclampsia, thyrotoxicosis, pulmonary insufficiency
- complete data;
- patient must have at least one year of regular follow-up and hCG monitoring following onset of remission;
- should have signed the consent form.
Exclusion Criteria:
- patients who are lost to follow-up or with incomplete data
- patients who underwent total hysterectomy for evacuation of molar pregnancy
- patients who are unable to complete the methotrexate treatment
- patients who get pregnant within a year following remission
- patients with a previous history of gestational trophoblastic neoplasia
- patients with medical problems/complications that inhibit administration of methotrexate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Chemoprohylaxis Group
Chemoprohylaxis Group: the treatment group, will be given a single course of methotrexate within fourteen days from molar evacuation.
Methotrexate will be given at 0.4 mg/kg intramuscularly per day for 5 days.
No chemotherapy will be administered if the hemoglobin is lower than 10 g/L, WBC is less than 3.0 x 10 g/L or more than 10.0 x 10 g/L, absolute neutrophil count is less than 1.5, platelet count is lower than 100,000/cu.cc., patient has elevated liver and renal function test and has concurrent infection.
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Patients will be given a single course of methotrexate within fourteen days from molar evacuation.
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Placebo Comparator: Control Group
Control Group: will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
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Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elevated HCG Level
Time Frame: 4-14 weeks
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4-14 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Agnes L. Soriano-Estrella, MD, University of the Philippines Manila
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Pregnancy Complications
- Pregnancy Complications, Neoplastic
- Trophoblastic Neoplasms
- Gestational Trophoblastic Disease
- Hydatidiform Mole
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Micronutrients
- Vitamins
- Reproductive Control Agents
- Hematinics
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Folic Acid
- Vitamin B Complex
Other Study ID Numbers
- NIH 2009-044
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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