| CTRI Number |
CTRI/2020/04/024780 [Registered on: 22/04/2020] Trial Registered Prospectively |
| Last Modified On: |
03/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Outcomes of Bone Metastases treated with Radiotherapy in Lung Cancer |
|
Scientific Title of Study
|
A Prospective Observational Study on Outcomes of Bone Metastases treated with Radiotherapy in Lung Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anil Tibdewal |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology, Homi Bhabha Block,Room No 1130,Tata Memorial Hospital
E Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
aniltibdewal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Tibdewal |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology, Homi Bhabha Block,Room No 1130,Tata Memorial Hospital
E Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
aniltibdewal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amiya Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology, Homi Bhabha Block,Room No 306,Tata Memorial Hospital
E Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
amiyaagrawal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital,
E Borges Road
Parel
Mumbai- 400012 |
|
|
Primary Sponsor
|
| Name |
Dr Anil Tibdewal |
| Address |
Tata Memorial Hospital
E Borges Road
Parel
Mumbai-400012 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
Department of Radiation Oncology, Homi Bhabha Block,Room No 306, E Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA |
022-24177000
aniltibdewal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TataMemorialHospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.All consecutive patients with histologically proven lung cancer with radiologically confirmed bone metastases and planned for radiotherapy at TMH.
2.All patients planned for radiotherapy at Tata Memorial Hospital.
|
|
| ExclusionCriteria |
| Details |
1.Age <18 years
2.Patients who are not willing to come for follow up after EBRT completion.
3.Patients with spinal cord compression at presentation.
4.Patients requiring reirradiation at the previously treated site.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate objective pain response at 2 and 4 weeks (+/-3 days) in lung cancer patients treated with radiotherapy for bone metastases |
2 and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate objective pain response of assessable patients at 3 and 6 months
Time to reirradiation for the same site
To evaluate the prognostic factors affecting the treatment response
To subjectively assess the quality of life using EORTC QOL and BM 22
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
27/04/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Consecutive patients eligible for study will be recruited and will be treated with radiotherapy using institutional dose fractionation. Pain response will be assessed at 2 and 4 weeks using Visual Analogue Pain Scale. |