Palliative breast radiotherapy in advanced incurable breast cancer
Phase 1
- Conditions
- Health Condition 1: null- Breast Cancer
- Registration Number
- CTRI/2015/12/006407
- Lead Sponsor
- Tata Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1.ECOG-0,1,2
2.Locally advanced breast cancer which is not amenable to curative surgery as decided by multidisciplinary tumor board.
3.Metastatic breast cancer patients:awaiting palliative locoregional radiotherapy for symptom(pain bleeding, ulceration, impending fungation)control.
4.who have completed a scheduled course of palliative chemotherapy and is felt to benefit from local radiation therapy.
Exclusion Criteria
1.Breast reconstruction using implants
2.Concurrent cytotoxic chemotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the toxicity using CTCAE version 4 and LENT SOMA toxicity criteria, in <br/ ><br>advanced incurable breast cancer patients treated with hypofractionated radiotherapy <br/ ><br>schedule of 35GY in 10 fractions rather than 15 fractionsTimepoint: Acute toxicity will be assessed weekly during radiotherapy then monthy for 1st three month after completion of radiotherapy.
- Secondary Outcome Measures
Name Time Method To assess the response of advanced incurable breast cancer patients treated with <br/ ><br>hypofractionated radiotherapy schedule of 35GY in 10fractions, 3 months after <br/ ><br>radiotherapy clinically and by regional PET-CT scan using PERCIST criteria <br/ ><br>To assess the impact of hypofractionated breast radiotherapy schedule of 35GY in 10 <br/ ><br>fractions over 2 weeks on quality of life in advanced incurable breast cancer patients using <br/ ><br>FACT B scores PHQ4 questionnaire <br/ ><br>Timepoint: Response assessment 3 month after completion of radiotherapy with clinical assessment and PET-CT scan <br/ ><br> <br/ ><br>QOL assessment just after completion and 3 months after completion of radiotherapy, then at 6 months and 1 year after completion of radiotherapy.