| 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
|
|
|
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
|
|
|
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. |