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临床试验/CTRI/2024/06/068752
CTRI/2024/06/068752尚未招募3 期

Docetaxel vs Carboplatin as radiosensitizer in Head And Neck cancer patients, unsuitable for cisplatin based chemoradiation - NI

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
尚未招募

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

入选标准

  • 1.Participants for radical or adjuvant CTRT for a histologically confirmed squamous cell of locally advanced head and neck region.
  • 2.Age : Any age above 18 years. No maximum age.
  • 3.ECOG performance status =2
  • 4.Participants must be unfit for Cisplatin

排除标准

  • 1.Participants who are receiving any other investigational agents.
  • 2.Primary sites of malignancy major salivary gland or nasopharynx or skin
  • 3.Patients with uncontrolled comorbidities precluding the use of docetaxel or Carboplatin
  • Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Clinically significant (i.e., active)cardiovascular disease: cerebrovascular accident/stroke (less than 6 months prior to enrollment), myocardial infarction (less than 6 months prior to enrollment), unstable angina, congestive heart failure (greater than equal to New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with severe renal and liver dysfunction Child pugh B or C
  • 5.Prior organ transplantation including allogeneic stem-cell transplantation.
  • 6.Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v5.0 Grade = 3).
  • 7.Pregnant and lactating women are excluded from this study

研究者

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