PER-083-04已完成未知
EXTENDED SCHEDULE OF GROWING DOSES OF TEMOZOLOMIDE COMPARED TO DACARBAZINE FOR METASTASIC MELANOMA TREATMENT STAGE IV: RANDOMIZED STUDY OF PHASE III OF THE MELANOMA GROUP OF THE EORTC
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Patients with histologically confirmed stage IV malignant metastatic melanoma (surgically incurable or inerachable), including unknown primary mucosal melanoma. Patients with disease in 2 regional lymphatic stations (even if they are contiguous) are considered stage IV. Ocular melanomas are excluded. Patients must present at least evaluable disease to meet the eligibility criteria for the study (the participation of patients with metastatic disease detectable only by PET) is not allowed [abbreviations in English of Tomography by Emission of Positrons]
- •Patients should not present clinical evidence of brain metastasis
- •Patients must not have received prior chemotherapy or any cytokine for stage IV disease. The following therapies are allowed: Coadjuvant therapy with cytokines or vaccines for stage I tumors, or not excised, Previous therapy with vaccines (other than cytokines) for stage IV disease, Non-radical surgery for stage IV disease, Chemotherapy or prior cytokine for local regional disease by perfusion therapy of the isolated limb
- •WHO performance status (ECOG) of 0-1
- •Age 18 years and older
- •The patients must present adequate hematological, renal and hematological functions according to the laboratory values that appear next in a period of 14 days, inclusive, before the randomization
- •Patients must have recovered from any effect produced by the practice of major surgery
- •Patients should not have frequent vomiting or medical conditions that could interfere with the oral intake of the medication, (eg, partial bowel obstruction)
- •Informed consent
排除标准
- •Clinical evidence of brain metastasis
- •Have previously received chemotherapy or any cytokine for stage IV disease. The following therapies are allowed: Coadjuvant therapy with cytokines or vaccines for stage I tumors, or not excised, Previous therapy with vaccines (other than cytokines) for stage IV disease, Non-radical surgery for stage IV disease, Chemotherapy or prior cytokine for local regional disease by perfusion therapy of the isolated limb
研究者
相似试验
进行中（未招募）
1 期
Extended schedule, escalated dose Temozolomide versusDacarbazine in Stage IV Metastatic Melanoma: ARandomized Phase III Study of the EORTC MelanomaGroupEUCTR2004-000654-23-ESEORTC850
进行中（未招募）
不适用
Extended schedule, escalated dose Temozolomide versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma GroupStage IV Metastatic MelanomaMedDRA version: 9.1Level: LLTClassification code 10027481Term: Metastatic melanomaEUCTR2004-000654-23-GBEORTC850
进行中（未招募）
不适用
Extended schedule, escalated dose Temozolomide versusDacarbazine in Stage IV Metastatic Melanoma: ARandomized Phase III Study of the EORTC MelanomaGroupStage IV Metastatic MelanomaMedDRA version: 7.0Level: PTClassification code 10027480EUCTR2004-000654-23-BEEORTC850
已完成
3 期
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)MelanomaNCT00091572Merck Sharp & Dohme LLC859
进行中（未招募）
不适用
Dose Intensified Rechallenge with Temozolomide, One Week on One Week Off versus Three Weeks on One Week Off in Patients with Progressive or Recurrent Glioblastoma (DIRECTOR)EUCTR2008-006871-60-ATniversity Hospital Heidelberg, Ruprechts-Karl-University Heidelberg166