NCT00094497 · STUDY IN CONTEXT

Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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.

exploratory · NOT_POSTED

TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime

Source null

→

primary · POSTED

participants who died among those randomized to first-line therapy

Source null

→

secondary · POSTED

Progression-free Survival

Source null

→

secondary · POSTED

scale ranged from 0 to 100 with higher score meaning greater quality of life

participants with data on both time points

→

secondary · POSTED

RECIST 1.0 was used to evaluate response

Source null

→

secondary · POSTED

complete response or disease-free by time of surgery

Source null

→

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

EORTC QLQ · Change in Quality of Life as Measured by QLQ-C30

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-adrenocortical-carcinoma
nct id: NCT00094497
qol key: qol-0002
source section id: NCT00094497-om-0002
source outcome index: 2
instrument: EORTC QLQ
instrument basis: matched 'qlq' in the study's own wording
scale title: Change in Quality of Life as Measured by QLQ-C30
measure definition: scale ranged from 0 to 100 with higher score meaning greater quality of life
time frame: baseline and 8 weeks
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: participants with data on both time points
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-adrenocortical-carcinoma
nct id: NCT00094497
trial label: Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
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: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0005
source section id
NCT00094497-om-0005
source outcome index
5
endpoint
TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime
endpoint definition
TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime
time origin
every 8 weeks until progression or until Dec 2010
analysis role
exploratory
reporting status
NOT_POSTED
data cutoff
Source null
population 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-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0000
source section id
NCT00094497-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
participants who died among those randomized to first-line therapy
time origin
every 8 weeks until death up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0001
source section id
NCT00094497-om-0001
source outcome index
1
endpoint
Progression-free Survival
endpoint definition
Progression-free Survival
time origin
every 8 weeks until progression or death up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0002
source section id
NCT00094497-om-0002
source outcome index
2
endpoint
Change in Quality of Life as Measured by QLQ-C30
endpoint definition
scale ranged from 0 to 100 with higher score meaning greater quality of life
time origin
baseline and 8 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
participants with data on both time points
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-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0003
source section id
NCT00094497-om-0003
source outcome index
3
endpoint
Best Overall Response Rate
endpoint definition
RECIST 1.0 was used to evaluate response
time origin
every 8 weeks up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0004
source section id
NCT00094497-om-0004
source outcome index
4
endpoint
Number of Disease-free Patients
endpoint definition
complete response or disease-free by time of surgery
time origin
every 8 weeks until progression (up to 5 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0000
arm key
OG000
arm label
EDP-M
regimen
etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)
analyzed count
151
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0000
arm key
OG001
arm label
Sz-M
regimen
streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
analyzed count
153
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0001
arm key
OG000
arm label
EDP-M
regimen
etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)
analyzed count
151
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0001
arm key
OG001
arm label
Sz-M
regimen
streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
analyzed count
153
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0002
arm key
OG000
arm label
EDP-M
regimen
etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0002
arm key
OG001
arm label
Sz-M
regimen
streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0003
arm key
OG000
arm label
EDP-M
regimen
etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)
analyzed count
151
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0003
arm key
OG001
arm label
Sz-M
regimen
streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
analyzed count
153
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0004
arm key
OG000
arm label
EDP-M
regimen
etopodide, doxorubicin, cisplatin and mitotane Etoposide Doxorubicin Cisplatin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)
analyzed count
151
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
outcome key
om-0004
arm key
OG001
arm label
Sz-M
regimen
streptozotocin and mitotane Streptozotocin Mitotane participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
analyzed count
153
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00094497-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
harm key
EG000
source section id
NCT00094497-ae
event group key
EG000
event group label
EDP-M
serious affected
86
serious at risk
148
other affected
0
other at risk
0
frequency threshold
5
collection period
up to 5 years
event definition
Other non-serious adverse events were not reliably collected and therefore not reported
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-adrenocortical-carcinoma
nct id
NCT00094497
harm key
EG001
source section id
NCT00094497-ae
event group key
EG001
event group label
Sz-M
serious affected
62
serious at risk
149
other affected
0
other at risk
0
frequency threshold
5
collection period
up to 5 years
event definition
Other non-serious adverse events were not reliably collected and therefore not reported
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

release id
clinical-indications-draft-1
disease state id
ds-adrenocortical-carcinoma
nct id
NCT00094497
qol key
qol-0002
source section id
NCT00094497-om-0002
source outcome index
2
instrument
EORTC QLQ
instrument basis
matched 'qlq' in the study's own wording
scale title
Change in Quality of Life as Measured by QLQ-C30
measure definition
scale ranged from 0 to 100 with higher score meaning greater quality of life
time frame
baseline and 8 weeks
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
participants with data on both time points
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice