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CTRI Number  CTRI/2024/08/072042 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 31/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Palliative Radiotherapy in Skeletal Metastasis  
Scientific Title of Study   Prospective Registry for Skeletal Metastasis treated with Palliative intent Radiation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Umesh Mahantshetty 
Designation  Professor, Radiation Oncology and Director 
Affiliation  Homi Bhabha Cancer Hospital and Research Center 
Address  Room no 105, Department of Radiation Oncology, Radiation Block, Homi Bhabha Cancer Hospital and Research Center, Aganampudi, Gajuwaka Mandalam, Visakhapatnam

Visakhapatnam
ANDHRA PRADESH
530053
India 
Phone  09819885774  
Fax    
Email  drumeshm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suneetha Lellapalli 
Designation  PG Resident 
Affiliation  Homi Bhabha Cancer Hospital and Research Center 
Address  Room no 104, Department of Radiation Oncology, Radiation Block, Homi Bhabha Cancer Hospital and Research Center, Aganampudi, Gajuwaka Mandalam, Visakhapatnam

Visakhapatnam
ANDHRA PRADESH
530053
India 
Phone  918555014754  
Fax    
Email  suneethalellapalli@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rohit Avinash Vadgaonkar 
Designation  Associate Professor 
Affiliation  Homi Bhabha Cancer Hospital and Research Center 
Address  Room no 104, Department of Radiation Oncology, Radiation Block, Homi Bhabha Cancer Hospital and Research Center, Aganampudi, Gajuwaka Mandalam, Visakhapatnam

Visakhapatnam
ANDHRA PRADESH
530053
India 
Phone  917973783256  
Fax    
Email  dr.ravad@gmail.com  
 
Source of Monetary or Material Support  
Homi Bhabha Cancer Hospital and Research Centre, Tata Memorial Centre, Visakhapatnam 
 
Primary Sponsor  
Name  Homi Bhabha Cancer Hospital and Research Center, Tata Memorial Centre, Visakhapatnam 
Address  Aganampudi, Gajuwaka Mandalam, Visakhapatnam (Andhra Pradesh)- 530053 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohit Avinash Vadgaonkar  Homi Bhabha Cancer Hospital and Research Centre  Room No. 105, Department of Radiation Oncology, Radiation block, Homi Bhabha Cancer Hospital and Research Centre, Aganampudi, Gajuwaka Mandalam, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH 
7972783256

dr.ravad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HBCHRC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (3) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (4) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (5) ICD-10 Condition: C43-C44||Melanoma and other malignant neoplasms of skin, (6) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (7) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (8) ICD-10 Condition: C60||Malignant neoplasm of penis, (9) ICD-10 Condition: C62||Malignant neoplasm of testis, (10) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (11) ICD-10 Condition: C69-C72||Malignant neoplasms of eye, brain and other parts of central nervous system, (12) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (13) ICD-10 Condition: C76-C80||Malignant neoplasms of ill-defined, other secondary and unspecified sites, (14) ICD-10 Condition: C7A||Malignant neuroendocrine tumors, (15) ICD-10 Condition: D49||Neoplasms of unspecified behavior,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  a. Patients with histologically confirmed malignancy with symptomatic metastatic bone disease detected on cross sectional imaging
b. If bone metastases are asymptomatic or minimally symptomatic (without opioid need) will be considered as high risk bone metastases if any of the following criteria is met:
1. More than 50% cortical destruction
2. More than 3 cm maximum diameter
3. Axila cortical involvement more than 3 cm
4. Multifocal lytic disease 
 
ExclusionCriteria 
Details  1. Patients who had previously received radiation therapy in the study region concerned.
2. Patients with any comorbidities that attributes to the present symptoms (intervertebral disc prolapse, spinal cord compression, and fractures post-spinal fixation)
3. Leptomeningeal disease.
4. Serious medical co-morbidities that preclude RT.
5. Patients who are diagnosed with prostate & haematolymphoid malignancy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Assess incidence of Skeletal Related events (SRE)  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To Evaluate pain response in patients with Symptomatic bone metastasis  6 months 
To evaluate patterns of analgesic usage in patients with symptomatic bone metastasis  6 months 
To document post-radiation acute toxicities  3 months 
To document post-radiation late toxicities  12 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   19/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  

The third most common organ to be affected by metastatic disease is bone, which is a frequent manifestation of advanced malignancy. Bone metastases (BM) lead to several morbidities and lower quality of life. Patients with BM are susceptible to high rates (50-70%) of complications such as paraplegia, fractures, and acute or chronic pain. It has been observed that these complications can be reduced by certain bone-modifying agents such as bisphosphonates and Radiotherapy (RT). Research studies have shown that RT substantially decreases complications in symptomatic or high-risk asymptomatic BM disease patients. So in this observational study, we aim to evaluate skeletal-related events (SRE) in both symptomatic and high-risk asymptomatic BM (>50% cortical destruction, > 3 cm maximum diameter, axial cortical involvement of > 3 cm, multi-focal lytic lesion) patients treated with RT. Patients with histologically confirmed malignancy diagnosis with BM and fulfilling inclusion criteria will be screened and invited to participate. Those who give written informed consent will be enrolled in the study. Incidence of SRE will be assessed initially at 6 months. SRE constitutes spinal cord compression, pathological fractures, and /or orthopedic surgery in the irradiated bony region. Pain response and analgesic usage patterns will be evaluated, and post-RT acute and late toxicities will be documented as per Common Toxicities Criteria for Adverse Events (CTCAE) v5.0.  

 
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