Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05224934
• Other study ID #: NCC-007744
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Ning-Ning Lu
• Phone: +868611804268
• Email: Ning-Ning.Lu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radiotherapy Side Effect
• Retroperitoneal Sarcoma
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Radiation:
• ultra-hypofractionated radiotherapy
stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively

Locations

Country	Name	City	State
China	Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-operative complications	The proportion of patients who suffer from	From surgery date up to 7 days later