HIGH DOSE RADIOTHERAPHY IN SOFT TISSUE SARCOMA
Phase 2
- Conditions
- Health Condition 1: C49- Malignant neoplasm of other connective and soft tissue
- Registration Number
- CTRI/2023/11/060048
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age: >15years.
Hemoglobin >9% pretreatment.
Biopsy proven soft tissue sarcoma.
Site: extremities, trunk, head and neck.
Size <20cms.
Resectable and borderline resectable tumors.
Informed consent.
ECOG PS 0-2.
Exclusion Criteria
No histopathological proof or malignancy.
Doubtful follow-up.
Previous history of radiotherapy in target area.
Uncontrolled co-morbid conditions e.g. hypertension, diabetes mellitus, coronary artery disease.
Contraindications of CT/MRI.
Deranged LFT, KFT.
Recurrent disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess major wound complication rates post surgery. <br/ ><br>Pathological response rateTimepoint: Major wound complication rates post surgery are assessed within 6 months post surgery. <br/ ><br>Pathological response rate
- Secondary Outcome Measures
Name Time Method radiological tumor response post radiotherapy.Timepoint: radiological tumor response is assessed one week before surgery.;to assess early and late complications post surgery.Timepoint: early and late complications are assessed at 6 weeks, 4 months, 6 months post surgery.;to assess local control and disease free survival post surgery.Timepoint: local control and disease free survival are assessed up-to 6 months post surgery.