| CTRI Number |
CTRI/2023/02/049773 [Registered on: 15/02/2023] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Stereotactic body radiation therapy in lymph nodal oligometastatic disease |
|
Scientific Title of Study
|
A prospective study to assess the feasibility of stereotactic body radiation therapy (SBRT) in lymph nodal oligometastatic disease (LN-SBRT) |
| Trial Acronym |
LN-SBRT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Khosla |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Radiotherapy Office, Ground Floor, Nehru Extension Block, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09876638478 |
| Fax |
|
| Email |
dr_divya_khosla@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Khosla |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Radiotherapy Office, Ground Floor, Nehru Extension Block, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09876638478 |
| Fax |
|
| Email |
dr_divya_khosla@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Khosla |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Radiotherapy Office, Ground Floor, Nehru Extension Block, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09876638478 |
| Fax |
|
| Email |
dr_divya_khosla@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical education and Research (PGIMER) CHANDIGARH
SECTOR 12, CHANDIGARH, INDIA, 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
SECTOR 12, CHANDIGARH, INDIA, 160012 |
| 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 |
| Divya Khosla |
PGIMER |
DEPARTMENT OF RADIOTHERAPY and ONCOLOGY, PGIMER, SECTOR 12, CHANDIGARH
Chandigarh
CHANDIGARH |
09876638478
dr_divya_khosla@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PGIMER,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Stereotactic body radiation therapy in lymph nodal oligometastasis from various cancers |
The study will be conducted in patients with lymph nodal oligometastasis from various cancers. the treatment will be completed in 3 to 7 fractions. Local control, toxicity and quality of life will be assessed at 6 months and 1 year to determine the impact of treatment on patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Lymph node oligometastatic disease in the neck, mediastinum, retroperitoneum, or pelvis
2) All primary tumors of colorectal, gastric, esophagus, lung, breast, gynaecological cancers or any other site
3) KPS ≥ 70
4) Age > 18 years
|
|
| ExclusionCriteria |
| Details |
More than 5 metastases
2) KPS ≤ 60
3) Pre-existing collagen vascular disease
4) Age < 18 years
5) Pregnant and Lactating women
6) Disseminated disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To assess Overall survival
2) To assess Progression Free Survival
|
6 months, 1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To evaluate adverse events according CTCAE
2)To evaluate chemotherapy-free survival
3)Quality of life with EORTC QLC C30
|
At 3 months, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/02/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
The
present study aims to assess the feasibility and efficacy of stereotactic
body radiation therapy in lymph nodal oligometastasis from various cancers. Local control, toxicity and quality of life will be assessed to determine the impact of treatment on the patient.
|
|