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.
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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