Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: comparison between 2 fractionation schedules of
radiotherapy in two
arms i.e. conventional fractionated
radiotherapy and hypofractionated radiotherapy
: To assess local toxicity and qu
Sponsors
Chittaranjan National Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: 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 0-2. 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.
Exclusion criteria
Exclusion criteria: 1.Age 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare acute toxicities between hypofractionated radiotherapy and conventional radiotherapy to chest wall in Post mastectomy breast cancer patients using 3D-CRT technique. 2. To compare Quality of Life of the patients treated by the regimens of either of the above two arms.Timepoint: Upto 3 months for acute toxicities and upto 9 months for quality of life assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare late toxicities between hypofractionated radiotherapy and conventional radiotherapy to chest wall in Post mastectomy breast cancer patients using 3D-CRT techniqueTimepoint: 3 years | — |
Countries
India
Contacts
Public ContactRaka Banerjee
Chittaranjan national cancer institute
Outcome results
None listed