Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003702
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
1999-11-01
Brief Title:
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus Pulsed Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
OBJECTIVES
I Compare the efficacy of methotrexate vs dactinomycin as measured by complete response rate in patients with low-risk gestational trophoblastic neoplasia
II Compare the toxicity of these regimens in these patients III Determine whether the definition of persistent gestational trophoblastic neoplasia is accurate as determined by the likelihood that the beta human chorionic gonadotropin HCG titer would decline on the day treatment is initiated
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity
ARM II Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity All patients continue on treatment until 1 beta human chorionic gonadotropin HCG titer is below the institutional normal Patients then receive 1 additional consolidation treatment
Patients are followed every 4 weeks for 1 year
I Compare the efficacy of methotrexate vs dactinomycin as measured by complete response rate in patients with low-risk gestational trophoblastic neoplasia
II Compare the toxicity of these regimens in these patients III Determine whether the definition of persistent gestational trophoblastic neoplasia is accurate as determined by the likelihood that the beta human chorionic gonadotropin HCG titer would decline on the day treatment is initiated
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity
ARM II Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity All patients continue on treatment until 1 beta human chorionic gonadotropin HCG titer is below the institutional normal Patients then receive 1 additional consolidation treatment
Patients are followed every 4 weeks for 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2011-02026 | REGISTRY | None | None |
| ECOG-G174 | None | None | None |
| CDR0000066809 | None | None | None |
| GOG-0174 | OTHER | None | None |
| GOG-0174 | OTHER | None | None |