High Dose Rate Interstitial Brachytherapy as Monotherapy for Extremities Soft Tissue Sarcoma: A Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- To evaluate the feasibility of interstitial brachytherapy as monotherapy in cases of extremity soft tissue sarcoma
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
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
- •Pregnant women
- •Ulcerated/Infected wound
- •Multifocal disease
- •Prior history of radiation to same /adjacent site
- •Medical or psychological illness which make them inappropriate candidate for surgery.
Outcomes
Primary Outcomes
To evaluate the feasibility of interstitial brachytherapy as monotherapy in cases of extremity soft tissue sarcoma
Time Frame: Data reporting on feasibility and safety at 24 months
Secondary Outcomes
- 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.)
Investigators
Bharti Devnani
AIIMS Jodhpur