Health Condition 1: C49- Malignant neoplasm of other connective and soft tissue
Conditions
Interventions
Intervention1: Ultra Hypofractionated Radiotherapy(UH-NART): Intervention Details-
Dose & Schedule 25 30 Gy in 5 fractions 5 6 Gy/fraction, given on alternate days over 2 3 weeks
Technique: IMRT/VMAT
standard GTV CTV PTV margins
Image Guidance: Daily IGRT (CBCT/MVCT)
Monitoring: Toxicity assessment using RTOG/CTCAE v5.0
Surgery: Planned 5 8 weeks post-radiotherapy
Adjuvant Therapy: As per institut
standard GTV CTV PTV margins
Image Guidance: As per institutional protocol (2 5 times/week)
Monitoring: Toxicity assessment using RTOG/CTCAE v5.0
Surgery: Planned 5 8 weeks post-radiotherapy
Adjuvant
Sponsors
Tata Memorial Centre Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: greater than or equal to 18 years of age Karnofsky Performance Status KPS 70 or above Core needle biopsy obtained for pathologic confirmation of primary soft tissue sarcoma FNCLCC grading intermediate or high Site extremities and limb girdles (scapula and pelvis) Localised disease primary or recurrent Size less than 30cm Prior inappropriate biopsy or unplanned surgery in single specimen which is planned for re-surgery as per clinical decision MR imaging of the primary tumour at diagnosis Medically and surgically operable documentation of resectability after appropriate evaluation by orthopaedic oncosurgeons Informed consent obtained prior to inclusion Patient willing and reliable for follow up and QOL
Exclusion criteria
Exclusion criteria: Locally advanced presence of lymph nodes and metastatic disease Prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields. Pregnant women Round cell sarcoma histologies Patients with a synchronous primary cancer requiring treatment STS of headneck retroperitoneum or chestwall regions Tumor size greater than or equal to 30 cm in any plane Tumours requiring vascular reconstruction Patients with known immunosuppression HIV or history of longterm steroid intake or uncontrolled diabetes HbA1C greater than 7 Complete microscopic resection of tumour deemed unfeasible or doubtful Prior piece meal unplanned surgery Patients unfit for general anaesthesia medically inoperable Any contraindication to radiotherapy like DNA repair syndromes Unable to follow up or poor logistic or social support
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-yr local recurrence free survival (LRFS)Timepoint: Assessed up to 3 years after surgery/treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Major wound complication rate within 90 days after surgery Acute radiation toxicity (within 6 weeks of radiotherapy completion) Late radiation toxicity (fibrosis, edema, joint stiffness) Disease Free Survival (DFS) Overall Survival (OS) Radiological response using RECIST criteria Pathological necrosis percentage R0 resection rates Functional outcome using Toronto Extremity Salvage Score (TESS) Patient satisfaction using EORTC OUT-PATSAT7 questionnaire Direct patient expenditure (travel, food, stay)Timepoint: Major wound complication rate -Within 90 days after surgery Acute radiation toxicity (RTOG/CTCAE grading)-Within 6 weeks after completion of radiotherapy Late radiation toxicity (fibrosis, subcutaneous edema, joint stiffness, skin toxicity)-Assessed from 6 weeks post-RT up to 3 years follow-up Disease Free Survival (DFS)-3 years after treatment Overall Survival (OS)-3 years after treatment Radiological response assessed using RECIST criteria on MRI-4 8 weeks after completion of radiotherapy Pathological tumor necrosis percentage-At time of surgery R0 resection rate (complete surgical resection with negative margins)-At time of surgery Functional outcome assessed using Toronto Extremity Salvage Score (TESS)-At baseline (enrollment) and during follow-up up to 3 years Patient experience assessed using EORTC OUT-PATSAT7 questionnaire-At baseline (enrollment) and during follow-up visits Direct expenditure incurred by patients (travel, stay, food costs)-During treatment and follow-up period | — |
Countries
India
Contacts
Public ContactDr Jifmi Jose Manjali
Tata Memorial Centre
Outcome results
None listed