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临床试验/CTRI/2021/05/033625
CTRI/2021/05/033625已完成2 期

A prospective comparative study between conventional fractionated radiotherapy and hypofractionated radiotherapy by using 3D-CRT technique with respect to toxicity and quality of life in postmastectomy breast carcinoma.

Chittaranjan National Cancer Institute0 个研究点目标入组 52 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
52

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.Age greater than equal to 18years and less than 70years.
  • 2.Female breast cancer patients.
  • 3.Histopathologically proven Infiltrating Ductal and Infiltrating Lobular carcinoma of the
  • 4.Patients who will undergo Modified Radical Mastectomy with adequate Axillary
  • Dissection in our institution and will be indicated for post mastectomy chest wall
  • radiotherapy.
  • 5.Breast carcinoma patients with documented ER,PR and Her2neu status.
  • 6.No other primary malignancy in any other parts of the body.
  • 7.No history of previous any chest wall irradiation.
  • 8.Eastern Cooperative Oncology Group(ECOG) Performance status 0-2.
  • 9.Patients without any serious co-morbidities like IHD,CVA,Coagulation and Bleeding
  • 10.Patients with normal haematological findings of Hb greater than 10gm/dl,TLC greater than 4000/cumm and
  • Platelet Count of greater than 1lacs/cumm.
  • 12.Patients with normal Kidney and Liver Function Test.
  • 13.Patients with normal Pulmonary Function Test.
  • 14.Patients who will give consent to participate in the study.

排除标准

  • 1.Age <18 years and >70years.
  • 2.Male breast cancer patients.
  • 3.Patients with a histopathological finding other than Invasive Lobular and Ductal
  • 4.Breast carcinoma patients withdistant metastasis.
  • 5.Patients with inoperable,clinically fixed,and matted lymph nodes.
  • 6.Patients with inadequate or no axillary dissection.
  • 7.Patients with any other primary malignant tumour.
  • 8.Patients with any chronic dermatological or connective tissue disorders that may interfere
  • with radiation induced acute skin toxicity assessment.
  • 9.History of any previous chest wall irradiation.
  • 10.Patients with Eastern Cooperative Oncology Group(ECOG)Performance Score >2.
  • 11.Patients with serious active comorbidities like:
  • History of unstable angina and/or congestive heart failure requiring hospitalization in the
  • last 6months.
  • *History of myocardial infarction within the last 6months.
  • Acute or chronic bacterial or fungal infection requiring intravenous antibiotics at the
  • time of patient registration.
  • Chronic Obstructive Pulmonary Disease with abnormal Pulmonary Function Test.
  • Clinical jaundice and bleeding disorders
  • 12.Patients with deranged Liver and Kidney function test results
  • 13.Patients who are HBsAg,Anti HCV antibody and HIV reactive.**

研究者

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