TriangleNCT00091572 · CITED IN SOURCE DOCUMENTS
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2017-06-06
The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Histologically confirmed, stage IV, surgically incurable melanoma * Age 18 years or older * World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Meets protocol requirements for specified laboratory values * Must be able to take oral medication * Must be disease free from cancer for period of 5 years (except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin). * Women of childbearing potential and men must be practicing a medically approved contraception. * Must provide written informed-consent to participate in the study. * Must have full recovery from major surgery or adjuvant treatment * No clinically uncontrolled infectious disease including HIV or AIDS-related illness Exclusion Criteria: * Ocular melanomas * Brain Metastases * Prior cytokine or chemotherapy for stage IV disease * Pregnant or nursing women
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
- intervention Names
- Drug: Temozolomide
- label
- A
- type
- EXPERIMENTAL
- description
- dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
- intervention Names
- Drug: Dacarbazine
- label
- B
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- A
- description
- oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.
- name
- Temozolomide
- other Names
- Temodal, Temodar, SCH 52365
- type
- DRUG
- arm Group Labels
- B
- description
- intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.
- name
- Dacarbazine
- other Names
- DTIC-Dome
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 859
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
- measure
- Overall Survival
- time Frame
- The final analysis was to be performed when at least 616 deaths had occurred.
- secondary Outcomes
- description
- 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.
- measure
- Progression Free Survival
- time Frame
- Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.
- description
- 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.
- measure
- Objective Response Rate in Subjects With Measurable Lesions
- time Frame
- Treatment continued until disease progression or unacceptable toxicity.
- description
- 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.
- measure
- Duration of Objective Response
- time Frame
- Treatment continued until disease progression or unacceptable toxicity.
Full study description
- brief Summary
- The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.
Source references
- references
- citation
- Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18.
- pmid
- 21600759
- type
- RESULT
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-4292383fe9f1574b22a8
- requested nct id
- NCT00101218
- primary nct id
- NCT00091572
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- end exclusive
- true
- id
- nct-edge-4292383fe9f1574b22a8
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00101218
- occurrences
- context exact
- se of temozolomide was compared with dacarbazine in a multicenter trial by the European Organisation for Research and Treatment of Cancer (EORTC) (EORTC-18032 [NCT00101218]) that randomly assigned 859 patients. No improvement was seen in OS or PFS for the temozolomide group, and this dose and schedule resulted in more toxicity th
- end
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- exact text
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- start
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- unicode_code_points
- source file
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- source file sha256
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- source retrieved at
- 2026-09-09T23:22:15.974415+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- 10578b000af9132c9cfe25a00f45be6680f43e992f5c12f2b6697492c4a5ca2e
- source title
- Melanoma Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: May 2, 2025
- datetime
- 2025-05-02T12:00:00Z
- display
- May 2, 2025
Preserved source evidence · Not medical advice