NCT01502696Unknown3 期
Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.
European Organisation for Research and Treatment of Cancer - EORTC59 个研究点 分布在 12 个国家目标入组 1,200 人开始时间: 2012年10月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 1,200
- 试验地点
- 59
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk.
The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be between 18-70 years old.
- •Subjects must have histologically documented ulcerated primary cutaneous melanomas with T(2-4)b N0M
- •Adequate resection of ulcerated primary cutaneous melanoma. 1 to 2 cm normal tissue excision margins according to Breslow thickness are recommended. In the head and neck areas and in case of locations distally on extremities, narrower margins are acceptable as long as they are radical (see Appendix F). Subjects must have recovered from the effects of recent surgery.
- •SNB must occur within 12 weeks prior randomization.
- •Subjects must have an ECOG performance status of 0 or 1 (See Appendix B).
- •Subjects must have adequate bone marrow, renal and hepatic function as defined by the following parameters obtained up to maximum 12 weeks prior to randomization:
- •Hematology:
- •WBC >= 3.0 x 109/L
- •Neutrophils > 1.5 x 109/L
- •Platelets > 100 x 109/L
- •Hemoglobin >= 9 g/dL or 5.6 mmol/L
- •Adequate Renal and Hepatic function:
- •Serum creatinine < 2.0 mg/dL or < 140 µmol/L
- •SGOT and SGPT < 2 times upper normal limit of laboratory normal (ULN)
排除标准
- •No mucosal melanoma nor ocular melanoma.
- •No evidence of nodal involvement confirmed by sentinel lymph node biopsy (SNB). Sentinel Node staging after the excision of the primary must be done between the date of final excision of the primary and the date of randomization.
- •No evidence of regional nor distant lymph node metastases nor satellites/in-transit metastases (even if they have been resected).
- •No evidence of distant metastasis on clinical examination, CT/MRI of full chest, abdomen and pelvis. Neck CT/MRI if head and neck primary.
- •No clinical evidence of brain metastasis.
- •No pregnant women
- •No breast feeding women
- •No patients with a medical condition requiring chronic systemic corticosteroids are not eligible.
- •No experimental therapy within 30 days prior to randomization in this study.
- •No prior chemotherapy, immunotherapy/vaccine, hormonal or radiation therapy for melanoma.
- •No prior treatment with interferon-alfa for any reason.
- •No history of prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
- •No severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) nor symptomatic ischemic heart disease.
- •No thyroid dysfunction not responsive to therapy.
- •No poorly controlled (HBA1C>8%) diabetes mellitus or uncontrolled diabetes mellitus, i.e. elevated fasting serum glucose should be < 110% ULN).
- •No active autoimmune disease.
- •No active and/or uncontrolled infection, including active hepatitis.
- •No history of seropositivity for HIV.
- •No history of neuropsychiatric disorder requiring hospitalization.
- •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 registration in the trial.
研究组 & 干预措施
PEG IFN alfa-2b
Experimental
干预措施: PEG IFN alfa-2b (Biological)
Observation
No Intervention
结局指标
主要结局
Relapse-free survival (RFS)
时间窗: 6.3 years from first patient in
次要结局
- Distant metastases-free survival (DMFS)(7.8 years from first patient in)
- Overall survival (OS)(7.8 years from first patient in)
- Quality of life(6 years from from first patient in)
- Occurence of Adverse Events(6.3 years from first patient in)
研究者
研究点 (59)
Loading locations...
相似试验
已完成
3 期
Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With MelanomaMelanomaSkin CancerNCT00002882M.D. Anderson Cancer Center140
进行中（未招募）
2 期
Adjuvant Nivolumab & Low Dose Ipilimumab for Stage III & Resected Stage IV MelanomaMelanomaNCT02656706Brown University22
已完成
3 期
PegIntron Versus IntronA in CMAJCC Stage II (EADO 2001/CMII Trial)Neoplasm MetastasisMelanomaNCT00221702University Hospital, Bordeaux898
暂停
2 期
Neoadjuvant T-VEC in High Risk Early MelanomaMelanomaNCT04427306University of California, Davis6
已完成
不适用
IL-2 "SELECT" Tissue Collection Protocol in Patients With Advanced MelanomaMalignant MelanomaNCT01288963Beth Israel Deaconess Medical Center153