CLINICAL TRIAL TO ASSESS THE NON-INFERIORITY OF CONCURRENT CHEMO-RADIOTHERAPY IN LOCALLY ADVANCED BREAST CANCER
- Conditions
- Health Condition 1: null- LOCALLY ADVANCED BREAST CANCER PATIENTS
- Registration Number
- CTRI/2014/12/005239
- Lead Sponsor
- CANCER INSTITUTE WIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 < 1.5 mg/dl, SGOT, SGPT and serum alkaline phosphatase should be less than twice normal)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Pathological complete response (PCR) <br/ ><br>Timepoint: 3 years <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. 5-year Disease free survival <br/ ><br>2. 5-year Overall survival <br/ ><br>3.Toxicity <br/ ><br>4.Quality of Life (QOL) <br/ ><br>Timepoint: 5 years follow-up