Health Condition 1: null- 1.Histologically confirmed preinvasive or invasive, Stage I â?? III breast cancer at initial presentation 2. Considered for whole breast reconstruction 3. Merits adjuvant RT
Conditions
Interventions
Intervention1: Hypofractionated radiotherapy: Patients will receive 40Gy in 15 fractions over 3 weeks
Control Intervention1: Conventional radiotherapy: Patients will receive 50Gy in 25 fractions over
Sponsors
Dr Prof Rajendra Badwe
Eligibility
Inclusion criteria
Inclusion criteria: 1. Known case of pre-invasive or invasive breast carcinoma (any histological subtype) 2. Stage I â?? III (Operable breast cancer or Locally Advanced breast cancer) at initial presentation 3. Age > 18 years 4. Undergone IBR following total mastectomy. 5. Eligible for adjuvant RT as per institutional protocol 6. Willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Histological diagnosis of phyllodes or sarcoma of the breast 2. Male breast cancer 3. History of receipt of previous RT to the chest wall 4. Pregnant unless willing to terminate pregnancy prior to initiation of radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Satisfaction with breast reconstruction and outcome of surgery 2.Late normal tissue effects (shrinkage / fibrosis of reconstructed breast) Timepoint: 1.Satisfaction with breast reconstruction and outcome of surgery 2.Late normal tissue effects (shrinkage / fibrosis of reconstructed breast) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health related Quality of life (HRQOL) 2. Complication rates like fat necrosis, infection, re-surgery 3. Influence of breast reconstruction on the radiation field design and technique 4. Clinical outcome: loco-regional control, disease free survival, distant metastasis free survival and overall survival at 2 and 5 years Timepoint: 2 and 5 years | — |
Countries
India
Contacts
Public ContactTabassum Wadasadawala
TATA MEMORIAL HOSPITAL
Outcome results
None listed