RCT on the Efficacy of Methotrexate for the Prevention of GTD

April 16, 2020 updated by: University of the Philippines

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

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

99

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Manila
      • Taft Avenue, Ermita, Manila, Manila, Philippines, 1000
        • Philippine General Hospital, University of the Philippines Manila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Patients will be given a single course of methotrexate within fourteen days from molar evacuation.
Placebo Comparator: Control Group
Control Group: will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
Other Names:
  • Bee ALL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elevated HCG Level
Time Frame: 4-14 weeks
  1. Diagnosis of postmolar gestational trophoblastic diseases will be based on the occurrence of any of the following conditions:

    • high level of hCG more than 4 weeks post-evacuation (serum level of 20,000mlU/m)
    • progressively increasing or plateuing hCG values at any time after evacuation (minimum of 3 weekly determinations)
    • clinical or histologic evidence of metastasis at any site
    • persistently elevated hCG titer at 14 weeks post-evacuation
    • elevation of previously normal hCG titer after evacuation provided the diagnosis of pregnancy is excluded
  2. Toxicity brought about by the administration of methotrexate will be graded based on the WHO toxicity scoring system.
4-14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Agnes L. Soriano-Estrella, MD, University of the Philippines Manila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

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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