Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
5 other identifiers
interventional
240
1 country
1
Brief Summary
Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedResults Posted
Study results publicly available
May 15, 2018
CompletedMay 15, 2018
February 1, 2016
11.1 years
November 1, 1999
November 2, 2017
April 12, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.
Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
Number of participants with a maximum grade of 3 or higher during the treatment period.
Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.
Secondary Outcomes (1)
Number of Patients With a Decline of hCG on Day 1 of Treatment
Prior to study entry and on Day 1 of treatment
Study Arms (2)
Arm I (methotrexate)
EXPERIMENTALPatients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
Arm II (dactinomycin)
EXPERIMENTALPatients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
Interventions
Given IV
Given intramuscularly
Eligibility Criteria
You may qualify if:
- Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
- Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers
- Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
- Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum)
- Histologically proven nonmetastatic choriocarcinoma
- Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm)
- WHO score 0-6 (not including blood group or CT lung)
- No histologically confirmed placental site pseudotumor
- Must have undergone at least 1 uterine curettage
- Previously untreated disease
- Performance status - GOG 0-2
- WBC at least 3,000/mm\^3
- Granulocyte count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- Eastern Cooperative Oncology Groupcollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela M. Kuras on behalf of Virginia Filiaci
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Osborne
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
June 1, 1999
Primary Completion
July 1, 2010
Last Updated
May 15, 2018
Results First Posted
May 15, 2018
Record last verified: 2016-02