NCT05224934
Recruiting
Not Applicable
Full-target Ultra-hypofractionated Stereotactic Irradiation Orchestrated With Nodule Boost for Retroperitoneal Sarcoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country50 target enrollmentJanuary 1, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Soft Tissue Sarcoma
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Peri-operative complications
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
Investigators
NINGNING LU
Principle Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Eligibility Criteria
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
Exclusion Criteria
- •metastatic disease
- •Tumor was previously treated by radiotherapy
- •Involvement of liver, pancreatic head or duodenum
Outcomes
Primary Outcomes
Peri-operative complications
Time Frame: From surgery date up to 7 days later
The proportion of patients who suffer from
Study Sites (1)
Loading locations...
Similar Trials
Active, not recruiting
Phase 2
Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial TrunkResectable Soft Tissue SarcomaNCT04562480Mayo Clinic120
Withdrawn
Not Applicable
Hypofractionated Radiation Therapy Followed by Surgery in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral CavityStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Verrucous Carcinoma of the Oral CavityStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Verrucous Carcinoma of the Oral CavityTongue CancerNCT02295540Rutgers, The State University of New Jersey
Recruiting
Phase 2
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction AdenocarcinomaNCT06078709Mayo Clinic99
Active, not recruiting
Not Applicable
Feasibility Trial of Preoperative 5-Day Hypofractionated Radiotherapy for Primary Soft Tissue SarcomaSoft Tissue SarcomaNCT05776667Medical University of South Carolina16
Completed
Phase 2
Hypofractionated Radiotherapy Followed by Hypo-boost for Local Advanced NSCLCNon-small Cell Lung CancerNCT03900117Sun Yat-sen University77