Completed
Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
What is being tested
Temozolomide
+ Dacarbazine
Drug
Who is being recruted
Melanoma+9
+ Neoplasms
+ Neoplasms by Histologic Type
Over 18 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: October 2004
Summary
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 20, 2004
Actual date on which the first participant was enrolled.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.
Official TitleExtended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
859 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors
Criteria
10 inclusion criteria required to participate
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
Show More Criteria
4 exclusion criteria prevent from participating
Ocular melanomas
Brain Metastases
Prior cytokine or chemotherapy for stage IV disease
Pregnant or nursing women
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimentaltemozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
Group II
Active Comparatordacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers