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
- 2/3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- 1. To compare acute toxicities between hypofractionated radiotherapy and conventional
研究概览
简要总结
At a median follow up duration of 9 months for each patients enrolled in the study, there was no statistically significant difference in either acute toxicities or quality of life between the two arms of the study at any point of follow up. At last follow-up there was no incidence of locoregional failure in any patient of either arms. Hypofractionated chest wall radiotherapy was well tolerated with acceptable toxicities and better compliance with no event of treatment interruptions due to side effects or toxicities warranting hospitalizations. This study thus established the non-inferiority of hypofractionated radiotherapy to conventionally fractionated radiotherapy in postmastectomy breast cancer patients with reduced burden on health care resources and improved patient compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
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 breast.
- •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-
- •9.Patients without any serious co-morbidities like IHD,CVA,Coagulation and Bleeding disorders.
- •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 Carcinoma.
- •4.Breast carcinoma patients withdistant metastasis.
- •5.Patients with inoperable,clinically fixed,and matted lymph nodes.
- •6.Patients with inadequate or no axillary dissection.
- •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>
- •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.
结局指标
主要结局
1. To compare acute toxicities between hypofractionated radiotherapy and conventional
时间窗: Upto 3 months for acute toxicities and upto 9 months for quality of life assessment
radiotherapy to chest wall in Post mastectomy breast cancer patients using 3D-CRT
时间窗: Upto 3 months for acute toxicities and upto 9 months for quality of life assessment
technique.
时间窗: Upto 3 months for acute toxicities and upto 9 months for quality of life assessment
2. To compare Quality of Life of the patients treated by the regimens of either of the above
时间窗: Upto 3 months for acute toxicities and upto 9 months for quality of life assessment
two arms.
时间窗: Upto 3 months for acute toxicities and upto 9 months for quality of life assessment
次要结局
- To compare late toxicities between hypofractionated radiotherapy and conventional(radiotherapy to chest wall in Post mastectomy breast cancer patients using 3D-CRT)