| CTRI Number |
CTRI/2016/06/006981 [Registered on: 02/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of outcomes of radiotherapy in metastatic spinal cord compression in lung cancer |
|
Scientific Title of Study
|
A prospective observational study to evaluate the outcomes of radiotherapy in metastatic spinal cord compression in lung cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1670 Version 1.0 Dated 01/12/2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JPAgarwal |
| Designation |
Professor & Radiation Oncologist |
| Affiliation |
Tata Memorial Centre |
| Address |
ROOM 1127, DEPARMENT OF RADIATION ONCOLOGY, HOMI BHABA BLOCK,TATA MEMORIAL HOSPITAL
Mumbai
MAHARASHTRA
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177164 |
| Fax |
02224146937 |
| Email |
agarwaljp@tmc.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alisha Sharma |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
ROOM 1127, DEPARMENT OF RADIATION ONCOLOGY, HOMI BHABA BLOCK,TATA MEMORIAL HOSPITAL
Mumbai
MAHARASHTRA
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177164 |
| Fax |
02224146937 |
| Email |
ahsila111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alisha Sharma |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
ROOM 1127, DEPARMENT OF RADIATION ONCOLOGY, HOMI BHABA BLOCK,TATA MEMORIAL HOSPITAL
Mumbai
MAHARASHTRA
India
MAHARASHTRA
400012
India |
| Phone |
02224177164 |
| Fax |
02224146937 |
| Email |
ahsila111@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital, Dr. E Borges road, Parel, Mumbai |
| Type of Sponsor |
Government medical college |
|
|
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 JAI PRAKASH AGARWAL |
TATA MEMORIAL CENTRE, DEPARTMENT OF RADIATION ONCOLOGY |
Room No. 67 & 109,DR. E. BORGES ROAD, PAREL, MUMBAI 400012 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
02224177164
02224146937
agarwaljp@tmc.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Review Board I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
metastatic spinal cord compression in lung cancer, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
•Age 18 years and above
•NSCLC/SCLC
•Presence of solitary or multiple tumour deposits/soft tissue mass/metastatic disruption of the bony cortex around the spinal cord that are extrinsically compressing the thecal sac as diagnosed on MRI or CT or evidence of clinical myeloradiculopathy with or without osteolysis evident on X-Ray and or Bone Scan in patients with progressive neoplastic disease.
•Informed consent (although have requested for waiver of consent from IEC)
|
|
| ExclusionCriteria |
| Details |
•Surgical intervention for treatment of MSCC
•Previous irradiation in the affected region of the spine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective of this study is to evaluate the various radiotherapy regimen 2 weeks, 1 month and 6 months after completion of RT, with respect to :
•Pain Relief
•Improvement in motor function/Ambulatory status
•Sphincter control
|
NIL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine whether there is any difference in outcome with respect to overall survival. |
NA |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2016 |
| Date of Study Completion (India) |
30/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
a prospective observational study to evaluate
the outcomes of radiotherapy in patient of lung cancer with metastatic spinal
cord compression in terms of pain
relief, improvement in motor function, sphincter control and overall survival
at 6 months |