RCT on the Efficacy of Methotrexate for the Prevention of GTD

NCT01984099 | Completed Phase 3 DMC

• 1 other identifier: NIH 2009-044
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydatidiform Mole

Keywords

Postmolar Gestational Trophoblastic Disease, Hydatidiform Mole

Outcome Measures

Primary Outcomes (1)

• Elevated HCG Level

  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

Study Arms (2)

Chemoprohylaxis Group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Drug: Vitamin B Complex

Interventions

Methotrexate DRUG

Patients will be given a single course of methotrexate within fourteen days from molar evacuation.

Chemoprohylaxis Group

Vitamin B Complex DRUG

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

Also known as: Bee ALL

Control Group

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Philippines: lead

Study Sites (1)

Philippine General Hospital, University of the Philippines Manila

Taft Avenue, Ermita, Manila, Manila, 1000, Philippines

Location

MeSH Terms

Conditions

Hydatidiform Mole

Interventions

Methotrexate; Vitamin B Complex

Condition Hierarchy (Ancestors)

Gestational Trophoblastic Disease; Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Agnes L. Soriano-Estrella, MD

  University of the Philippines Manila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: December 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

PH (1)