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HIGH DOSE RADIOTHERAPHY IN SOFT TISSUE SARCOMA

PROSPECTIVE PHASE-II STUDY OF PREOPERATIVE STEREOTACTIC BODY RADIATION THERAPY IN SOFT TISSUE SARCOMA - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060048
Enrollment
30
Registered
2023-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C49- Malignant neoplasm of other connective and soft tissue

Interventions

Intervention1: Radiation therapy, Surgery: Patient will receive stereotactic body radiotherapy 30-40Gy/5#/alternate days to target site followed by surgery of primary site 4-6 weeks after completion o

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age: >15years. Hemoglobin >9% pretreatment. Biopsy proven soft tissue sarcoma. Site: extremities, trunk, head and neck. Size Resectable and borderline resectable tumors. Informed consent. ECOG PS 0-2.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
To assess major wound complication rates post surgery. Pathological response rateTimepoint: Major wound complication rates post surgery are assessed within 6 months post surgery. Pathological response rate

Secondary

MeasureTime frame
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.

Countries

India

Contacts

Public ContactGanta Mounika

All India Institute of Medical sciences

rambha151@gmail.com9310012026

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026