RCT on the Efficacy of Methotrexate for the Prevention of GTD

Sponsor

University of the Philippines (Other)

Overall Status

Completed

CT.gov ID

NCT01984099

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

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).

Study Design

Study Type:

Interventional

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 :

Dec 1, 2011

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

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 Names: Bee ALL

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 Names:

Bee ALL

Outcome Measures

Primary Outcome Measures

Elevated HCG Level [4-14 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

Female

Accepts 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