NCT00003702 · STUDY IN CONTEXT

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Eligible patients who received a random treatment allocation

→

primary · POSTED

Number of participants with a maximum grade of 3 or higher during the treatment period.

Eligible and treated patients

→

secondary · POSTED

Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start.

Eligible and evaluated patients

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-gestational-trophoblastic-tumor
nct id: NCT00003702
trial label: Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
outcome key
om-0000
source section id
NCT00003702-om-0000
source outcome index
0
endpoint
Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
endpoint definition
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.
time origin
Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients who received a random treatment allocation
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
outcome key
om-0001
source section id
NCT00003702-om-0001
source outcome index
1
endpoint
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
endpoint definition
Number of participants with a maximum grade of 3 or higher during the treatment period.
time origin
Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
outcome key
om-0002
source section id
NCT00003702-om-0002
source outcome index
2
endpoint
Number of Patients With a Decline of hCG on Day 1 of Treatment
endpoint definition
Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start.
time origin
Prior to study entry and on Day 1 of treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and evaluated patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
outcome key
om-0000
arm key
OG000
arm label
Arm 1: Methotrexate 30 mg/m2 IM Weekly
regimen
Arm 1: Methotrexate 30 mg/m2 IM weekly
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003702-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
outcome key
om-0000
arm key
OG001
arm label
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
regimen
Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
analyzed count
109
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003702-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
outcome key
om-0001
arm key
OG000
arm label
Arm 1: Methotrexate 30 mg/m2 IM Weekly
regimen
Arm 1: Methotrexate 30 mg/m2 IM weekly
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003702-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
outcome key
om-0001
arm key
OG001
arm label
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
regimen
Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
analyzed count
109
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003702-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
outcome key
om-0002
arm key
OG000
arm label
Enrolled Participants
regimen
Enrolled participants that had a subsequent hCG measurement after enrollment and before treatment
analyzed count
178
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003702-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
harm key
EG000
source section id
NCT00003702-ae
event group key
EG000
event group label
Arm 1: Methotrexate 30 mg/m2 IM Weekly
serious affected
0
serious at risk
107
other affected
50
other at risk
107
frequency threshold
0
collection period
Through Study completion, an average of 7 months.
event definition
The frequencies of any serious adverse event or other adverse events (grade 2 or higher) by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported. Adverse events were collected by Organ System Class.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gestational-trophoblastic-tumor
nct id
NCT00003702
harm key
EG001
source section id
NCT00003702-ae
event group key
EG001
event group label
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
serious affected
1
serious at risk
107
other affected
68
other at risk
107
frequency threshold
0
collection period
Through Study completion, an average of 7 months.
event definition
The frequencies of any serious adverse event or other adverse events (grade 2 or higher) by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported. Adverse events were collected by Organ System Class.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice