NCT00091572 · STUDY IN CONTEXT

Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

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. 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.

primary · POSTED

Overall Survival was defined as the time from the date of randomization to the date of death from any cause.

Intent to Treat Population

→

secondary · POSTED

Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.

Intent to Treat Population

→

secondary · POSTED

Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.

Intent to treat population with measurable disease at Baseline.

→

secondary · POSTED

Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.

All responders

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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-melanoma
nct id: NCT00091572
trial label: Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
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.
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: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-melanoma
nct id
NCT00091572
outcome key
om-0001
source section id
NCT00091572-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
time origin
The final analysis was to be performed when at least 616 deaths had occurred.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent to Treat Population
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-melanoma
nct id
NCT00091572
outcome key
om-0000
source section id
NCT00091572-om-0000
source outcome index
0
endpoint
Progression Free Survival
endpoint definition
Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.
time origin
Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent to Treat Population
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-melanoma
nct id
NCT00091572
outcome key
om-0002
source section id
NCT00091572-om-0002
source outcome index
2
endpoint
Objective Response Rate in Subjects With Measurable Lesions
endpoint definition
Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.
time origin
Treatment continued until disease progression or unacceptable toxicity.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat population with measurable disease at Baseline.
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-melanoma
nct id
NCT00091572
outcome key
om-0003
source section id
NCT00091572-om-0003
source outcome index
3
endpoint
Duration of Objective Response
endpoint definition
Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.
time origin
Treatment continued until disease progression or unacceptable toxicity.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All responders
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-melanoma
nct id
NCT00091572
outcome key
om-0000
arm key
OG000
arm label
Temozolomide
regimen
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
analyzed count
429
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00091572-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma
nct id
NCT00091572
outcome key
om-0000
arm key
OG001
arm label
Dacarbazine
regimen
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
analyzed count
430
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00091572-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma
nct id
NCT00091572
outcome key
om-0001
arm key
OG000
arm label
Temozolomide
regimen
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
analyzed count
429
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00091572-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma
nct id
NCT00091572
outcome key
om-0001
arm key
OG001
arm label
Dacarbazine
regimen
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
analyzed count
430
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00091572-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma
nct id
NCT00091572
outcome key
om-0002
arm key
OG000
arm label
Temozolomide
regimen
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
analyzed count
401
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00091572-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma
nct id
NCT00091572
outcome key
om-0002
arm key
OG001
arm label
Dacarbazine
regimen
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
analyzed count
388
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00091572-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma
nct id
NCT00091572
outcome key
om-0003
arm key
OG000
arm label
Temozolomide
regimen
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
analyzed count
55
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00091572-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma
nct id
NCT00091572
outcome key
om-0003
arm key
OG001
arm label
Dacarbazine
regimen
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00091572-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-melanoma
nct id
NCT00091572
harm key
EG000
source section id
NCT00091572-ae
event group key
EG000
event group label
Temozolomide
serious affected
124
serious at risk
419
other affected
394
other at risk
419
frequency threshold
5
collection period
Source null
event definition
Source null
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-melanoma
nct id
NCT00091572
harm key
EG001
source section id
NCT00091572-ae
event group key
EG001
event group label
Dacarbazine
serious affected
100
serious at risk
421
other affected
374
other at risk
421
frequency threshold
5
collection period
Source null
event definition
Source null
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