Hydatidiform MolePhase 3NCT01984099
RCT on the Efficacy of Methotrexate for the Prevention of GTD
A Phase 3 study testing Methotrexate and Vitamin B Complex in people with Hydatidiform Mole, run by University of the Philippines at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Hydatidiform Mole
- What is being tested?
- Methotrexate and Vitamin B Complex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 sitePhilippines
- Study dates
- Dec 2011to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine General Hospital, University of the Philippines Manila
Taft Avenue, Ermita, Manila, Manila, 1000
About this study
Official title: 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.
Read the 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).
- Conditions
- Hydatidiform Mole
- Being tested
- Methotrexate, Vitamin B Complex
- Keywords
- Postmolar Gestational Trophoblastic Disease, Hydatidiform Mole
- Medical subject headings
- Hydatidiform Mole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Patients will be given a single course of methotrexate within fourteen days from molar evacuation.
Vitamin B ComplexDrug
Also called Bee ALL
Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vitamin B Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydatidiform MoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnes L. Soriano-Estrella, MD, Principal investigator, University of the Philippines Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984099
- Sponsor's protocol ID
- NIH 2009-044
- Status last verified
- Apr 2020
- First submitted
- 7 Nov 2013
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole
- ClinicalTrials.gov ID
- NCT01984099
- Acronym / sponsor ID
- NIH 2009-044
- Conditions
- Hydatidiform Mole
- Keywords
- Postmolar Gestational Trophoblastic Disease, Hydatidiform Mole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemoprohylaxis Group | Active comparator | Drug: MethotrexateChemoprohylaxis 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 | Placebo comparator | Drug: Vitamin B ComplexControl Group: will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- complete data;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexatePatients will be given a single course of methotrexate within fourteen days from molar evacuation. | Drug | Chemoprohylaxis Group |
| Vitamin B ComplexAlso: Bee ALLPatients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously. | Drug | Control Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes L. Soriano-Estrella, MD principal investigator
University of the Philippines Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate and Vitamin B Complex in people with Hydatidiform Mole, run by University of the Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elevated HCG Level (time frame: 4-14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.