Health Condition 1: C492- Malignant neoplasm of connective and soft tissue of lower limb, including hip Health Condition 2: C491- Malignant neoplasm of connective and soft tissue of upper limb, including shoulder
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Control Intervention2: NIL: NIL
Sponsors
All India Institute of Medical Sciences Jodhpur
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the feasibility of interstitial brachytherapy as monotherapy in cases of extremity soft tissue sarcomaTimepoint: Data reporting on feasibility and safety at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Data reporting on Oncological outcomes-36 months | — |
Countries
India
Contacts
Public ContactBharti Devnani
AIIMS Jodhpur
Outcome results
None listed