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The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease
Last Updated on: 2013-11-15 16:07:06
Registry ID: PHRR131118-000141
Secondary Identification Number: NIH 2009-044


Scientific Title

The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease among Patients with High-Risk Hydatidiform Mole

Project Description

This is a randomized controlled, double blind trial that aims to evaluate the efficacy of methotrexate in preventing Post Molar Gestational Trophoblastic Disease (PMGTD) among patients with high-risk hydatidiform mole in our locality. Likewise, this study aims to determine the incidence of patients who develop PMGTD among those who received chemoprophylaxis and those who did not receive chemoprophylaxis, the toxicities brought about the administration of the methotrexate and the difference in time to normalization of βhCG and the average time to development of PMGTD following evacuation of molar products. Patients histopathologically diagnosed with complete hydatidiform mole, meeting at least one of the risk factors for the development of PMGTD, who underwent suction curettage for molar evacuation at a tertiary hospital in Metro Manila, will be randomly allocated to one of the two study groups: methotrexate (treatment) and placebo (control) groups. Routine baseline examination will be done for all patients at the start of the study, which includes diluted serum βhCG, complete blood count with platelet count and differential count, urinalysis, BUN, creatinine, ALT, AST, transvaginal ultrasound and chest X-ray PA upright. Patients in the treatment group will be given a single course of methotrexate (0.4 mg/kg/day administered intramuscularly for 5 days) within fourteen days from molar evacuation. On the other hand, patients in the control group will be given Bee All a Vitamin B complex drug given intramuscularly for 5 days. The Patient will be monitored for toxicities in the form of nausea, vomiting, stomatitis and rashes, which will be recorded and graded based on the WHO Toxicity Scoring System. One week following treatment, complete blood count, liver and kidney function tests will be taken for evaluation of any hematologic hepatic or renal toxicity. Patients serum βhCG titers will be monitored according to standard protocol: βhCG titer will be determined 1 week after molar evacuation and then every 2 weeks until the titers became for three consecutive determinations, after which βhCG monitoring will be done monthly for 6 months, then every 2 months for the next 6 months to complete a year. During the follow-up period, patients will be advised to avoid pregnancy and will be given a low-dose oral contraceptive pill immediately after evacuation.

NUHRA Details
NUHRA Regime NUHRA Classification NUHRA Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Project Duration
Start Date Duration in Months Target Completion Date Actual Completion Date
2007-09-03 12 2008-09-03 2013-03-29
Project Status

Completed

Implementing Agency (Primary Sponsor)

Name of Institution Classification Region LTO #
Philippine General Hospital, Department of Obstetrics and Gynecology Government NCR

Cooperating Agency (Secondary Sponsor)

None

Funding Agency (Sources of Monetary or Material Support)

1. National Institutes of Health - University of the Philippines - Manila

Contact for Public Queries

Name: Email Address: Phone Number: Postal Address:
Dr. Agnes Soriano-Estrella docagnes96@yahoo.com 5548400 2300 University of the Philippines - Philippine General Hospital (UP-PGH), Department of Obstetrics and Gynecology, Taft Ave, Ermita Manila 1000

Contact for Scientific Queries

Name: Email Address: Phone Number: Postal Address:
Dr. Agnes Soriano-Estrella docagnes96@yahoo.com 5548400 2300 University of the Philippines - Philippine General Hospital (UP-PGH), Department of Obstetrics and Gynecology, Taft Ave, Ermita Manila 1000

Investigating Team

Name Expertise Affiliation
Agnes Soriano-Estrella Obstetrics and Gynecology Trophoblastic Disease Philippine General Hospital, Department of Obstetrics and Gynecology
Maria Anna Luisa Festin Dalawangbayan, MD Obstetrics and gynecologic ultrasound Philippine General Hospital, Department of Obstetrics and Gynecology
Jimmy Billod, MD Fellow in training in Gynecologic Oncology Philippine General Hospital, Department of Obstetrics and Gynecology
Katherine Saravillo, MD Resident in Training Philippine General Hospital, Department of Obstetrics and Gynecology

Health Condition(s) or Problem(s) Studied

Gestational trophoblastic neoplasia Hydatidiform mole

Primary Outcomes

Criteria for the development for the postmolar gestational trophoblastic disease after administration of methotrexate or placebo: High level of βhCG more than 4 weeks post-evacuation (serum level of 20,000mlU/m), progressively increasing or plateauing hCG values at any time after evacuation (minimum 3 weekly determinations), clinical hystologic evidence of metastasis at any site, persistently elevated βhCG titer at 14 weeks post-evacuation and elevation of a previously normal βhCG titer after evacuation provided the diagnosis of pregnancy is ruled out. [Normal βhCG titer is defined as a value of less than or equal to 5 mlU/mL]. Toxicity brought about the administration of methotrexate will e graded based on the WHO toxicity scoring system.

Key Secondary Outcomes

Measure of safety as determined by the presence and grade of toxicity evaluated using the WHO toxicity scoring system. During and after treatment the patient was monitored foe toxicities in the form of nausea, vomiting, stomatitis and rashes. One week following treatment, complete blood count, liver, and kidney function tests were taken for evaluation of any hematologic, hepatic or renal toxicity. Patients were also interviewed and evaluated for other toxicities. These findings were recorded using the WHO toxicity scoring system.

Date of First Enrollment

2007-09-03

Recruitment Status

Completed

Countries of Recruitment

Philippines

Research Classification

Clinical Trial

Project Location & Institutional Ethics Review Board Which Approved the Study

Project Location Institutional Ethics Review Board
Philippine General Hospital, Department of Obstetrics and Gynecology University of the Philippines Manila - Research Ethics Board

FDA Document Tracking Number

Unspecified

FDA / ERC Approval Date

Unspecified

Amendment Approval Dates/Reasons

None

Key Inclusion and Exclusion Criteria (CT)

Inclusion Criteria: Diagnosis and molar evacuation done at the Department of Obstetrics and Gynecology of the Philippine General Hospital; Patients who will undergo suction and curettage for evaluation 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 the age of gestation of more than 6 weeks -Serum βhCG titer more than or equal to 100,00mlU/ml -theca lutein cysts more than or equal to 6cm in size -maternal age greater than or equal to 35 years -gravity 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 evaluation 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 Type

Interventional

Intervention Name

Methotrexate treatment

Intervention Description

Methotrexate treatment, 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.

Method of Allocation

Randomized

Masking / Blinding

Double Blind: The Patients, statistician, fellow a

Masking Details

None

Assignment

Parallel

Purpose

Efficacy of methotrexate for the prevention of Gestational Trophoblastic Disease

Phase

Phase II/III

Target Sample Size (Philippines)

70

Actual Sample Size (Philippines)

61

Reason for the difference between target & actual sample sizes

September 2007 to march 2013 has a total of 99 subjects recruited, however 38 subjects were lost to follow-up.

Date of first enrollment

2007-09-03

Research Utilization

None