Health Condition 1: null- LOCALLY ADVANCED BREAST CANCER PATIENTS
Conditions
Interventions
Intervention1: NEO-ADJUVANT CONCURRENT CHEMO-RADIATION THERAPY: Patients in this arm will receive I FEC on Day 1.
The dosage for the FEC is as follows
5-FU 600 mg/m2 - intravenous Day 1
Epir
Sponsors
CANCER INSTITUTE WIA
DEPT OF SCIENCE AND TECHNOLOGY GOVERNMENT OF INDIA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with Locally Advanced Breast Cancer - stages IIB , IIIA and IIIB-operable and inoperable 2. Patients PS I and II 3. Patients fit for anthracycline based chemotherapy â?? FEC and single agent Docetaxel 4. No previous chemotherapy or hormone therapy
Exclusion criteria
Exclusion criteria: 1. PS III and PS IV 2. Age > 65 yrs 3. Stage III C- ipsilateral supraclavicular node positive 4. Inflammatory Breast Cancer 5. Patients with co-morbidities that preclude the use of anthracylines such as cardiac disease, uncontrolled diabetes 6. Patients with liver dysfunction (s.bilirubin 7. Patients with fixed axillary nodes, multiple cutaneous nodules ( > 3) in the skin overlying the breast, ipsilateral arm lymphedema. 8. Patients with large and pendulous breasts on whom concurrent chemoradiation will have more skin toxicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pathological complete response (PCR) Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 5-year Disease free survival 2. 5-year Overall survival 3. Toxicity 4. Quality of Life (QOL) Timepoint: 5 years follow-up | — |
Countries
India
Contacts
Public ContactDR SRIDEVI VELUSWAMI
CANCER INSTITUTE (WIA)
Outcome results
None listed