Radiotherapy Side Effect, Retroperitoneal Sarcoma, Soft Tissue Sarcoma, Stereotactic Ablative Radiotherapy, Ultra-hypofractionated Radiotherapy
Conditions
Keywords
stereotactic ablative radiotherapy, hypofractionated radiotherapy, retroperitoneal sarcoma, soft tissue sarcoma, peri-operative complications
Brief summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
Interventions
RADIATIONultra-hypofractionated radiotherapy
stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-operative complications | From surgery date up to 7 days later | The proportion of patients who suffer from |
Countries
China
Contacts
Primary ContactNing-Ning Lu
Backup ContactShu-Lian Wang
Outcome results
None listed