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Preop chemoradiotherapy for sarcoma

Comparing the response and treatment complications of neoadjuvant chemo radiotherapy versus neoadjuvant radiotherapy in larger than 5 centimeter high grade soft tissue sarcoma of extremity between years 2018-2021

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150929024266N4
Enrollment
106
Registered
2019-11-24
Start date
2019-12-22
Completion date
Unknown
Last updated
2019-12-17

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

Conditions

Soft tissue sarcoma of the extremities. Malignant neoplasm of other connective and soft tissue

Interventions

Intervention 1: Intervention group: 3DCRT 46-50Gy/23-25 fr plus Concurrent Chemotherapy with Epirubicin and Ifosfamide and then Surgical Resection. Intervention 2: Control group: 3DCRT 46-50Gy/23-25 f

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Pathological diagnosis of soft tissue sarcoma in extremity Tumor size over 5 cm based on CT scan or MRI

Exclusion criteria

Exclusion criteria: Not tolerating chemotherapy due to underlying renal, hepatic or cardiac problems or insufficient bone marrow reserve Recurrent o metastatic tumors Pregnancy or breastfeeding

Design outcomes

Primary

MeasureTime frame
Treatment-induced toxicities. Timepoint: Weekly during intervention, 4, 12 and 24 weeks after intervention. Method of measurement: Interviewing patient and physical examination including inspection and palpation, lab data and imaging.;Pathological response. Timepoint: After surgery. Method of measurement: Inspection of surgical specimen by the pathologist and defining the extent of tumor tissue necrosis.

Secondary

MeasureTime frame
Post-op complications. Timepoint: 4 weeks after surgery. Method of measurement: Interviewing and examining the patient.;Local recurrence. Timepoint: 6,12 and 24 month after surgery. Method of measurement: Physical exam and imaging.;Distant metastasis. Timepoint: 6,12 and 24 month after surgery. Method of measurement: Physical exam and imaging.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Ghalehtaki

Tehran University of Medical Sciences

rezaght@gmail.com+98 21 6119 2520

Outcome results

None listed

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