Trial · NCT00094497

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

NCT00094497, Phase 3, Completed, Collaborative Group for Adrenocortical Carcinoma Treatment; results first posted 2016-09-21

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT). Trials, record NCT00094497. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00094497

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)
NCT number: NCT00094497
Status: Completed
Phases: Phase 3
Enrollment: 304 participants, actual
Lead sponsor: Collaborative Group for Adrenocortical Carcinoma Treatment
Conditions: Carcinoma, Adrenal Cortical
Interventions: Etoposide, Doxorubicin, Cisplatin, Streptozotocin, Mitotane
First posted: 2004-10-20
Last updated: 2016-09-21
Results first posted: 2016-09-21

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	every 8 weeks until death up to 5 years	participants who died among those randomized to first-line therapy
Secondary	Progression-free Survival	every 8 weeks until progression or death up to 5 years
Secondary	Change in Quality of Life as Measured by QLQ-C30	baseline and 8 weeks	scale ranged from 0 to 100 with higher score meaning greater quality of life
Secondary	Best Overall Response Rate	every 8 weeks up to 5 years	RECIST 1.0 was used to evaluate response
Secondary	Number of Disease-free Patients	every 8 weeks until progression (up to 5 years)	complete response or disease-free by time of surgery
Other	TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime	every 8 weeks until progression or until Dec 2010
Other	Pharmakinetics of Mitotane (Substudy)	11 time points in the first 12 weeks	To study the relationship between mitotane dose (daily and cumulative) and mitotane plasma concentrations using one of two pre-defined treatment regimens (high-dose and low-dose).
Other	Impact of Reaching Mitotane Blood Levels Between 14-20 mg/l in Both Arms on Survival and Overall Response Rate	every 8 weeks until progression or until Dec 2010

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	every 8 weeks until death up to 5 years		participants	NUMBER
SECONDARY	Progression-free Survival	every 8 weeks until progression or death up to 5 years		months	MEDIAN
SECONDARY	Change in Quality of Life as Measured by QLQ-C30	baseline and 8 weeks	participants with data on both time points	units on a scale	MEAN
SECONDARY	Best Overall Response Rate	every 8 weeks up to 5 years		participants	NUMBER
SECONDARY	Number of Disease-free Patients	every 8 weeks until progression (up to 5 years)		participants	NUMBER
OTHER_PRE_SPECIFIED	TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime	every 8 weeks until progression or until Dec 2010
OTHER_PRE_SPECIFIED	Pharmakinetics of Mitotane (Substudy)	11 time points in the first 12 weeks
OTHER_PRE_SPECIFIED	Impact of Reaching Mitotane Blood Levels Between 14-20 mg/l in Both Arms on Survival and Overall Response Rate	every 8 weeks until progression or until Dec 2010

Source ClinicalTrials.gov

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival	EDP-M		108		participants
Overall Survival	Sz-M		124		participants
Progression-free Survival	EDP-M		5.0	95% Confidence Interval 3.5 to 6.9	months
Progression-free Survival	Sz-M		2.1	95% Confidence Interval 2.04 to 2.33	months
Change in Quality of Life as Measured by QLQ-C30	EDP-M		-6.0	Standard Deviation 21.4	units on a scale
Change in Quality of Life as Measured by QLQ-C30	Sz-M		-7.7	Standard Deviation 25.6	units on a scale
Best Overall Response Rate	EDP-M	complete response	2		participants
Best Overall Response Rate	Sz-M	complete response	1		participants
Best Overall Response Rate	EDP-M	disease-free by time of surgery	4		participants
Best Overall Response Rate	Sz-M	disease-free by time of surgery	2		participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	EDP-M	151
Overall Study	STARTED	Sz-M	153
Overall Study	Treated	EDP-M	148
Overall Study	Treated	Sz-M	149
Overall Study	Received Second Line Therapy	EDP-M	84
Overall Study	Received Second Line Therapy	Sz-M	101
Overall Study	COMPLETED	EDP-M	151
Overall Study	COMPLETED	Sz-M	153
Overall Study	NOT COMPLETED	EDP-M	0
Overall Study	NOT COMPLETED	Sz-M	0

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	adrenal insufficiency	Endocrine disorders	EDP-M	5	148
serious	adrenal insufficiency	Endocrine disorders	Sz-M	1	149
serious	bone marrow toxicity	Blood and lymphatic system disorders	EDP-M	17	148
serious	bone marrow toxicity	Blood and lymphatic system disorders	Sz-M	3	149
serious	cardiovascular or thromboembolic events	Vascular disorders	EDP-M	10	148
serious	cardiovascular or thromboembolic events	Vascular disorders	Sz-M	0	149
serious	fatigue or general health deterioration	General disorders	EDP-M	8	148
serious	fatigue or general health deterioration	General disorders	Sz-M	7	149
serious	gastrointestinal disorder	Gastrointestinal disorders	EDP-M	6	148
serious	gastrointestinal disorder	Gastrointestinal disorders	Sz-M	12	149

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	EDP-M
Total, all-cause mortality	Sz-M
Total, other adverse events	EDP-M	0	0
Total, other adverse events	Sz-M	0	0
Total, serious adverse events	EDP-M	86	148
Total, serious adverse events	Sz-M	62	149

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22551107	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
EDP-M vs Sz-M: Number of Disease-free Patients	Trial comparisons
EDP-M vs Sz-M: Overall Survival	Trial comparisons
EDP-M vs Sz-M: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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