Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma

Study Overview
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Brief Summary
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To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma

Official Title
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Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Primary and Relapsed Retroperitoneal Sarcoma

Conditions
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Soft Tissue Sarcoma, Retroperitoneal Sarcoma, Radiotherapy Side Effect, Ultra-hypofractionated Radiotherapy, Stereotactic Ablative Radiotherapy

Intervention / Treatment
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* Radiation: ultra-hypofractionated radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary soft tissue sarcoma of retroperitoneal or infra-peritoneal spaces of pelvis Sarcoma not originated from bone structure, abdominal or gynecological viscera All disease can be included safely within one radiotherapy field Absence of extension through the sciatic notch or across the diaphragm Histologically proven, excluding the following subtypes: Gastro-intestinal stromal tumors (GIST), rhabdomyosarcoma, PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma ECOG performance status 0 to 2 American Society of Anesthesiologist (ASA) score ≤2 Normal renal function: Calculated Creatinine Clearance ≥50ml/min（by Cockcroft-Gault formula）and functional contralateral kidney by differential renal isotope scan Normal bone marrow and hepatic function. Contraception was needed for female patients of child-bearing age, or male patients whose partner had child-bearing age expected life expectancy longer than 5 years Written consent form was given prior to treatment Can safely be treated by radiotherapy and surgery Exclusion Criteria: metastatic disease Tumor was previously treated by radiotherapy Involvement of liver, pancreatic head or duodenum

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultra-hypofractionated radiotherapy<br>Patients receive ultra-hypo-fractionated radiotherapy with 25Gy to 50Gy in five fractions, followed by surgery done at 1 to 2 months post-RT | Radiation: ultra-hypofractionated radiotherapy<br>* stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-operative complications | The proportion of patients who suffer from | From surgery date up to 7 days later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic ablative radiotherapy, hypofractionated radiotherapy, retroperitoneal sarcoma, soft tissue sarcoma, peri-operative complications