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RCT on the Efficacy of Methotrexate for the Prevention of GTD

Primary Purpose

Hydatidiform Mole

Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
Methotrexate
Vitamin B Complex
Sponsored by
University of the Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydatidiform Mole focused on measuring Postmolar Gestational Trophoblastic Disease, Hydatidiform Mole

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Philippine General Hospital, University of the Philippines Manila

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Chemoprohylaxis Group

Control Group

Arm Description

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.

Control Group: will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.

Outcomes

Primary Outcome Measures

Elevated HCG Level
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 Toxicity brought about by the administration of methotrexate will be graded based on the WHO toxicity scoring system.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2013
Last Updated
April 16, 2020
Sponsor
University of the Philippines
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1. Study Identification

Unique Protocol Identification Number
NCT01984099
Brief Title
RCT on the Efficacy of Methotrexate for the Prevention of GTD
Official Title
The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Philippines

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydatidiform Mole
Keywords
Postmolar Gestational Trophoblastic Disease, Hydatidiform Mole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemoprohylaxis Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Control Group: will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Patients will be given a single course of methotrexate within fourteen days from molar evacuation.
Intervention Type
Drug
Intervention Name(s)
Vitamin B Complex
Other Intervention Name(s)
Bee ALL
Intervention Description
Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
Primary Outcome Measure Information:
Title
Elevated HCG Level
Description
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 Toxicity brought about by the administration of methotrexate will be graded based on the WHO toxicity scoring system.
Time Frame
4-14 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes L. Soriano-Estrella, MD
Organizational Affiliation
University of the Philippines Manila
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philippine General Hospital, University of the Philippines Manila
City
Taft Avenue, Ermita, Manila
State/Province
Manila
ZIP/Postal Code
1000
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

RCT on the Efficacy of Methotrexate for the Prevention of GTD

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