Effect of radiation doses on heart in thoracic (chest) cancer patients
Not Applicable
- Conditions
- Health Condition 1: C159- Malignant neoplasm of esophagus, unspecifiedHealth Condition 2: C37- Malignant neoplasm of thymusHealth Condition 3: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2024/01/061777
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Pathological or cytological evidence of malignancy
2. Patients treated with thoracic radiotherapy ± chemotherapy (neoadjuvant, adjuvant, and definitive radiation)
3. Patients willing to sign the written informed consent
4. Patients willing for follow up
Exclusion Criteria
1. Age <18 years
2. Reirradiation to the thoracic area where cardiac structures already received a significant dose
3. Life expectancy of less than 6 months
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To identify the high-risk cohort of patients for cardiac toxicity in patients treated with Radiotherapy ± Chemotherapy for thoracic malignancies <br/ ><br>AND <br/ ><br>To evaluate any grade cardiac toxicities in thoracic cancer patients treated with definitive Radiotherapy ± Chemotherapy <br/ ><br>Timepoint: Baseline, 6 months, 12 months and yearly thereafter
- Secondary Outcome Measures
Name Time Method Correlation of Cardiac Biomarkers with Cardiac Toxicity and Survival in Severely high-risk patientsTimepoint: 6 months, 12 months and yearly thereafter;Cumulative Incidence of = Grade 3 Cardiac ToxicityTimepoint: 6 months, 12 months and yearly thereafter;Number of patients requiring Cardiac InterventionTimepoint: 6 months, 12 months and yearly thereafter;To assess the impact of dosimetric parameters of the whole heart and its substructuresTimepoint: 6 months, 12 months and yearly thereafter;To identify radiological and functional imaging correlates of cardiac toxicityTimepoint: 6 months, 12 months and yearly thereafter