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RCT on the Efficacy of Methotrexate for the Prevention of GTD

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ClinicalTrials.gov Identifier: NCT01984099
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : November 14, 2013
Sponsor:
Information provided by (Responsible Party):
University of the Philippines

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.

Condition or disease Intervention/treatment Phase
Hydatidiform Mole Drug: Methotrexate Drug: Vitamin B Complex Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole
Study Start Date : December 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013


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.
Drug: Methotrexate
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.
Drug: Vitamin B Complex
Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
Other Name: Bee ALL




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984099


Locations
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Philippines
Philippine General Hospital, University of the Philippines Manila
Taft Avenue, Ermita, Manila, Manila, Philippines, 1000
Sponsors and Collaborators
University of the Philippines
Investigators
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Principal Investigator: Agnes L. Soriano-Estrella, MD University of the Philippines Manila

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Responsible Party: University of the Philippines
ClinicalTrials.gov Identifier: NCT01984099     History of Changes
Other Study ID Numbers: NIH 2009-044
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013
Keywords provided by University of the Philippines:
Postmolar Gestational Trophoblastic Disease, Hydatidiform Mole
Additional relevant MeSH terms:
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Hydatidiform Mole
Folic Acid
Vitamin B Complex
Folic Acid Antagonists
Gestational Trophoblastic Disease
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Pregnancy Complications, Neoplastic
Pregnancy Complications
Vitamins
Methotrexate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors