此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

2018年2月9日 更新者：Lu Si、Peking University Cancer Hospital & Institute

A Multicenter, Randomized, Controlled, Phase III Trial Comparing High-Dose IFN-a2b With Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

This is a a multicenter, randomized, controlled, phase III trial comparing High-Dose IFN-a2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma.The study objective is to compare efficacy and safety of High-dose IFN-a2b and temozolomide-based chemotherapy as adjuvant therapy.

研究概览

地位

未知

条件

干预/治疗

详细说明

The patients who comply with the inclusion and exclusion criteria will be enrolled. The estimated recruiting duration is 36 months. Patients with resected mucosal melanoma were randomized into two groups: HDI group (group A, treated with i.v. 15×10^6U/m^2/d IFN-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10^6U IFN-a2b three times per week for 48 weeks), and chemotherapy group (group B, per os 200 mg/m^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles). All patients will be followed for at least 2 years.

研究类型

介入性

注册 (预期的)

204

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100142
        • 招聘中
        • Beijing Cancer Hospital
        • 接触：
        • 接触：
        • 副研究员：
          • Bin Lian, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age more than 18 years;
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  3. Pathologically confirmed diagnosis of mucosal melanoma;
  4. Completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted);
  5. No prior systemic adjuvant therapy or regional radiotherapy;
  6. No evidence of distant metastatic disease evaluated by means of lymph nodes ultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract, single-photon emission computed tomography (CT) of bone, and whole-body spiral CT or positron emission tomography-CT (PET-CT);
  7. Normal bone marrow function; and adequate liver and renal function [including white blood cell (WBC) count > 3,000/mm^3;absolute neutrophil count > 1,500/mm^3; platelets >100,000/mm^3; serum creatinine less than two times of the upper limit of normal (ULN); bilirubin less than 1.5 times of ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times of ULN; international normalized ratio less than 1.5 times of ULN; and partial thromboplastin time less than ULN].

Exclusion Criteria:

  1. Cutaneous melanoma or ocular melanoma or melanoma of unknown primary site;
  2. Incomplete resection or primary tumor unable to be resected;
  3. A second cancer diagnosis;
  4. Definite medical history of cirrhoses of the liver or autoimmune diseases;
  5. Severe depression; and pregnant or lactating female.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Temozolomide Plus Cisplatin
per os 200 mg/m^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles
药品：Temozolomide Plus Cisplatin

Temozolomide is the oral analog of dacarbazine (DTIC), shows potential advantages over dacarbazine.

Cisplatin is an agent that can potentially enhance the activity of temozolomide.

其他名称：
  • 顺铂
  • Temodal.
有源比较器：High-Dose IFN-a2b
Participants will be treated with i.v. 15×10^6U/m^2/d IFN-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10^6U IFN- a2b three times per week for 48 weeks.
药品：High-Dose IFN-a2b
Interferon belongs to the large class of glycoproteins known as cytokines.
其他名称：
  • 内含子

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Relapse-free survival (RFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.
大体时间：Participants will be followed for an expected average of 24 months
Participants will be followed for an expected average of 24 months

次要结果测量

结果测量
大体时间
Distant metastasis-free survival(DMFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.
大体时间：Participants will be followed for an expected average of 24 months
Participants will be followed for an expected average of 24 months
Overall survival (OS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.
大体时间：From date of randomization until the date of death from any cause, assessed up to 48 months
From date of randomization until the date of death from any cause, assessed up to 48 months
Number of Participants with Adverse Events of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 12 months
Participants will be followed for the duration of hospital stay, an expected average of 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking University Cancer Hospital & Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年2月1日

初级完成 (预期的)

2018年2月1日

研究完成 (预期的)

2019年2月1日

研究注册日期

首次提交

2014年2月8日

首先提交符合 QC 标准的

2018年2月9日

首次发布 (实际的)

2018年2月19日

研究记录更新

最后更新发布 (实际的)

2018年2月19日

上次提交的符合 QC 标准的更新

2018年2月9日

最后验证

2018年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BCHMMAT001

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Temozolomide Plus Cisplatin的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Germany

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

订阅