| CTRI Number |
CTRI/2024/01/061777 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of radiation doses on heart in thoracic (chest) cancer patients |
|
Scientific Title of Study
|
The Impact of Radiation Therapy doses on Cardiac Toxicity and Survival in Thoracic Malignancies - An Ambispective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anil Tibdewal |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 306, Homi Bhabha Block Building, Department of Radiation Oncology, Thoracic Division, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9757352747 |
| Fax |
|
| Email |
aniltibdewal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jai Prakash Agarwal |
| Designation |
Professor and Head of Department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 1132, Homi Bhabha Block Building, Department of Radiation Oncology, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9867241770 |
| Fax |
|
| Email |
agarwaljp@tmc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Anil Tibdewal |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 306, Homi Bhabha Block Building, Department of Radiation Oncology, Thoracic Division, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9757352747 |
| Fax |
|
| Email |
aniltibdewal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel, Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, E Borges Road, Parel, Mumbai, 400012 Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Tibdewal |
Tata Memorial Hospital |
Room number 306, Homi Bhabha Block Building, Department of Radiation Oncology, E Borges Road, Parel
Mumbai
MAHARASHTRA |
9757352747
aniltibdewal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II, Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, (2) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (3) ICD-10 Condition: C37||Malignant neoplasm of thymus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify the high-risk cohort of patients for cardiac toxicity in patients treated with Radiotherapy ± Chemotherapy for thoracic malignancies
AND
To evaluate any grade cardiac toxicities in thoracic cancer patients treated with definitive Radiotherapy ± Chemotherapy
|
Baseline, 6 months, 12 months and yearly thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cumulative Incidence of ≥ Grade 3 Cardiac Toxicity |
6 months, 12 months and yearly thereafter |
| To assess the impact of dosimetric parameters of the whole heart and its substructures |
6 months, 12 months and yearly thereafter |
| Correlation of Cardiac Biomarkers with Cardiac Toxicity and Survival in Severely high-risk patients |
6 months, 12 months and yearly thereafter |
| To identify radiological and functional imaging correlates of cardiac toxicity |
6 months, 12 months and yearly thereafter |
| Number of patients requiring Cardiac Intervention |
6 months, 12 months and yearly thereafter |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Radiotherapy is employed in the management of various thoracic malignancies, such as those affecting the lung, esophagus, and thymus. Due to the proximity of these tumors to the heart, there is increased risk of cardiac complications, which depend upon a variety of factors including patient age, cardiac history, comorbidities, radiation dose and concurrent chemotherapy regimens. The primary objective of this study is to evaluate the occurrence of cardiac side effects in patients subjected to radiotherapy for thoracic malignancies. Our observational study aims to assess potential correlations between these cardiac complications and clinical, imaging, and laboratory parameters. Additionally, we seek to ascertain the predictive value of dose-related factors in anticipating the likelihood of cardiac sequelae in such patients. |