EUCTR2004-000654-23-BE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 MelanomaGroup
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 850
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(a) Patients with histologically confirmed, surgically incurable or unresectable metastatic melanoma including mucosal and unknown primary. Ocular melanomas are excluded.
- •(b) Patients with evidence of brain metastases are not eligible.
- •(c) Patients must not have received any prior cytokine or chemotherapy for stage IV disease. The following are allowed:
- •? Adjuvant cytokine or vaccine therapy for resected stage I to III disease
- •? Previous vaccine therapy (other than cytokine) for stage IV disease
- •? Palliative surgery for stage IV disease
- •? Prior Cytokine or chemotherapy for local-regional disease by isolated limb perfusion
- •All patients must have discontinued prior allowable therapy for at least 4 weeks prior to
- •randomization.
- •(d) Patients must have WHO (ECOG) performance status of 0 or 1.
- •(e) Age greater than or equal to 18 years.
- •(f) Patients must have adequate hematological, renal and liver function.
- •(g) Patients must have recovered from any effects of major surgery or previous adjuvant treatment.
- •(h) Patients should not suffer from frequent vomiting or medical condition which could interfere with oral medication intake (eg, partial bowel obstruction).
- •(i) Patients should not have suffered from previous cancer (unless a DFS interval of at least 5 years) or suffer from concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
- •(j) Patients should not suffer from any known clinically uncontrolled infectious disease. Patients who are HIV positive or have AIDS are excluded.
- •(k) Patients should not be pregnant or nursing.
- •(l) Women of childbearing potential should be using an effective method of contraception. Women of childbearing potential must have a negative urine or serum pregnancy test 14 days prior to randomization and be practicing medically approved contraceptive precautions for at least 6 months after completion of treatment as directed by their physician.
- •(m) Men should use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician.
- •(n) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial.
- •(o) Before patient randomization, written informed consent must be obtained according to ICH/GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- 未提供
研究者
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