Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
Temozolomide
+ Dacarbazine
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.859 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives