Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast
Conditions
Interventions
Intervention1: Adjuvant Radiation 26 Gy in 5 fractions over 5 days: Adjuvant radiation dose will be 26 Gy delivered over 5 days (daily treatment nearly 5 mins)
Control Intervention1: Adjuvant radiatio
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: � Age 18 - 75 years � Female patients � Biopsy proven IDC (any grade) � Stage: T1-4b; N0-3; M0 � LVSI/PNI-allowed � ER/PR/Her2neu-Any � Karnofsky performance score 70 and above � Pulmonary function test-WNL � 2DECHO-LVEF 50-60% � The patient must sign an informed consent before entry into the study
Exclusion criteria
Exclusion criteria: � Age >75 years and � Not a surgical candidate � Previous history of radiotherapy � Recurrent disease � Patients with significant co-morbid condition � History of previous malignancy � KarnofskyPerformance score below 70 � Not compliant for regular follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i) To compare Ipsilateral breast Tumor recurrence Free survival (IBTR)Timepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| i) To compare Loco-regional recurrence free survival (LRRFS) ii) To compare photographic cosmetic outcome (one pre RT, one month after RT and then every six months for three years) ii) To assess QoL by EORTC QLQ-C30 and BR-23 questionnaires iii) To correlate neutrophil count, lymphocyte and CD4 count with RFSTimepoint: 5 years | — |
Countries
India
Contacts
Public ContactSupriya Mallick
National Cancer Institute, AIIMS, New Delhi
Outcome results
None listed