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CTRI Number  CTRI/2024/06/068831 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   High-Dose Internal Radiation Therapy Alone for Soft Tissue Cancer in Limbs: A Study Plan 
Scientific Title of Study   High Dose Rate Interstitial Brachytherapy as Monotherapy for Extremities Soft Tissue Sarcoma: A Prospective Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bharti Devnani 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  Department of Radiation Oncology AIIMS Jodhpur, Basni, Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8860728352  
Fax    
Email  bhartidevnani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bharti Devnani 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  Department of Radiation Oncology AIIMS Jodhpur, Basni, Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8860728352  
Fax    
Email  bhartidevnani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bharti Devnani 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  Department of Radiation Oncology AIIMS Jodhpur, Basni, Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8860728352  
Fax    
Email  bhartidevnani@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Marudhar Industrial Area, Basni, Jodhpur, Rajasthan, India. Pin -342005 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  All India Institute of Medical Sciences, Marudhar Industrial Area, Basni, Jodhpur, Rajasthan, India. Pin -342005 
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 Bharti Devnani  AIIMS Jodhpur  Departmnent Of Radiation Oncology, Room No-4, Ground floor, Marudhar Industial area Basni AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN 		 8860728352

bhartidevnani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C492||Malignant neoplasm of connective and soft tissue of lower limb, including hip, (2) ICD-10 Condition: C491||Malignant neoplasm of connective and soft tissue of upper limb, including shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age 18-70 years, ECOG PS 0-2
2.Biopsy-proven localized extremities soft tissue sarcoma of any Grade
3.Size up to 15 cm in the greatest dimension
4.Surgically resectable with R0 resection 
 
ExclusionCriteria 
Details  1. Pregnant women
2. Ulcerated/Infected wound
3. Multifocal disease
4. Prior history of radiation to same /adjacent site
5. Medical or psychological illness which make them inappropriate candidate for surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the feasibility of interstitial brachytherapy as monotherapy in cases of extremity soft tissue sarcoma  Data reporting on feasibility and safety at 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate local control rates with Interstitial brachytherapy as monotherapy (IBM) is Extremity soft tissue sarcoma (ESTS)
2.To report the Adverse events at specific times using the Common Terminology Criteria for Adverse Events (CTCAE) v 6.0 , RTOG score and LENT SOMA scoring.
3.To study the functional outcomes of extremities using objective assessment- Musculoskeletal Tumor
Rating Scale - MSTS Scale) and patient reported outcomes- TESS scoring system at different time frames. 
4.To study the Quality of life using FACT-G at different time frames.  
5.To develop a standardized operating procedure for the implementation of IBM in ESTS. 		 Data reporting on Oncological outcomes-36 months 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   15/07/2024 
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="3"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
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  

Extremities soft tissue sarcoma (ESTS) are rare tumors. Treatment of ESTS has evolved significantly over the last decade. ESTS were traditionally treated with amputation and radical resections. The addition of external beam radiotherapy/ Brachytherapy has improved oncological outcomes. The current prospective study aims to study the feasibility, safety, and early oncological outcomes of Interstitial brachytherapy as monotherapy in radiation naive extremities soft tissue sarcoma post surgery. It will help us gather the acute toxicity profile, quality of life, and functional outcome data of patients of soft tissue sarcomas treated at our center with brachytherapy. The study will give our institutional data of this standard procedure, local control rates, and physician and patient-reported outcomes and help in defining standard operative procedure and pave the path of future randomized trials.

 
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