Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma

Phase 2

Recruiting

• Conditions: Radiotherapy Side Effect; Soft Tissue Sarcoma; Retroperitoneal Sarcoma; Stereotactic Ablative Radiotherapy; Ultra-hypofractionated Radiotherapy
• Interventions: Radiation: ultra-hypofractionated radiotherapy

• Registration Number: NCT05224934
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-01-25
• Last Update Submitted: 2022-01-25
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultra-hypofractionated radiotherapy	ultra-hypofractionated radiotherapy	Patients receive ultra-hypo-fractionated radiotherapy with 25Gy to 50Gy in five fractions, followed by surgery done at 1 to 2 months post-RT

Primary Outcome Measures

Name	Time	Method
Peri-operative complications	From surgery date up to 7 days later	The proportion of patients who suffer from

Trial Locations

Locations (1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China