NCT00094497 · OUTCOME
Best Overall Response Rate
Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT) · Source last updated 2016-09-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- every 8 weeks up to 5 years
What was measured
RECIST 1.0 was used to evaluate response
Groups in this outcome
EDP-M
etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)
Sz-M
streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| EDP-M | 151 |
|---|
| Sz-M | 153 |
|---|
Reported measurements
complete response
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| EDP-M | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sz-M | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
disease-free by time of surgery
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| EDP-M | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sz-M | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
partial response
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| EDP-M | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sz-M | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
stable disease
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| EDP-M | 53 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sz-M | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
progressive disease
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| EDP-M | 43 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sz-M | 88 | Not reported | Not reported | Not reported | Not reported |
|---|
did not receive treatment
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| EDP-M | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sz-M | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
could not be evaluated
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| EDP-M | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sz-M | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- complete response
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- title
- disease-free by time of surgery
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 11
- title
- partial response
- categories
- measurements
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 34
- title
- stable disease
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 88
- title
- progressive disease
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- title
- did not receive treatment
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 13
- title
- could not be evaluated
- denoms
- counts
- group Id
- OG000
- value
- 151
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- RECIST 1.0 was used to evaluate response
- groups
- description
- etopodide, doxorubicin, cisplatin and mitotane
Etoposide
Doxorubicin
Cisplatin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)
- id
- OG000
- title
- EDP-M
- description
- streptozotocin and mitotane
Streptozotocin
Mitotane
participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)
- id
- OG001
- title
- Sz-M
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- every 8 weeks up to 5 years
- title
- Best Overall Response Rate
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice