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NCT05224934 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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