Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
None listed
Sponsors
Apollo Proton Cancer Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed breast cancer patients being planned for proton therapy 2. Patients who have the ability to understand and be willing to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1. Patients or legal guardians who are unable to understand informed consent document 2. Metastatic disease 3. Connective tissue disorders such as scleroderma, rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5 â?? year rate of acute coronary event defined as a myocardial infarction, death due to cardiac event, symptomatic congestive cardiac failure, requirement of coronary intervention and development of an arrhythmia.Timepoint: 5 â?? year rate of acute coronary event defined as a myocardial infarction, death due to cardiac event, symptomatic congestive cardiac failure, requirement of coronary intervention and development of an arrhythmia. | — |
Secondary
| Measure | Time frame |
|---|---|
| 5- year loco-regional controlTimepoint: Assessed at the end of 5 year;5-year disease free survival (calculated from date of diagnosis (surgery) till clinico-radiological progression or death)Timepoint: Assessed at the end of 5 years;5-year overall survival (measured from the date of diagnosis to death due to any cause or last follow-up of diagnosis (surgery) till clinico-radiological progression or death.Timepoint: Assessed at the end of 5 years;Cardiac function: Deterioration in cardiac function defined a reduction of 5% or more in EF values lower than 54%, along with signs and/or symptoms of heart failure (HF), or a reduction of 10% or more in EF values lower than 54%, without clinical findings of HF. o The development of new regional wall motion abnormality. o Decline in global and segmental longitudinal strain by 15 %. Timepoint: Pre-treatment, post treatment, 3months, 6 months, 1, 3, 5 years;Correlation of cardiac function with above mentioned parameters, dosimetric parameters pertaining to heart, LV, coronary arteryTimepoint: Pre-treatment, post treatment, 3months, 6 months, 1, 3, 5 years;Correlation of segmental RWMA and decline of segmental longitudinal strain with mean and D0.02 and D0.2 cc of individual coronary and ventricular segments.Timepoint: Pre-treatment, post treatment, 3months, 6 months, 1, 3, 5 years;Cosmesis as per the Harvard Breast Cosmesis scale for subjective and BCTOS scale for objective assessmentTimepoint: Pre-treatment, post treatment, 3months, 6 months, 1, 3, 5 years;Dosimetric comparison of proton therapy plan with Tomotherapy plan.Timepoint: Pre-treatment;Quality of Life of all patients treated with PBT using site specific EORTC QOL tools EORTC-QLQ-C30 [ Time Frame: Pre-PBT, immediately after PBT, 3months, 6 months, 1, 3, 5 years] EORTC-QLQ-BR23 [ Time Frame: Pre-PBT, immediately after PBT, 3 months, 6 months, 1, 3, 5 years] Timepoint: Time Frame: Pre-PBT, immediately after PBT, 3months, 6 months, 1, 3, 5 years;Toxicity | — |
Countries
India
Contacts
Public ContactSapna Nangia
Apollo Proton Cancer Centre
Outcome results
None listed