Pre-surgery ultra-hypofractionated radiation for retroperitoneal soft tissue sarcoma
Full-target Ultra-hypofractionated Stereotactic Irradiation Orchestrated With Nodule Boost for Retroperitoneal Sarcoma
This study tests a very short course of pre-surgery high-dose radiation followed by surgery to see if it is safe and manageable for people with retroperitoneal soft tissue sarcoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05224934 on ClinicalTrials.gov |
What this trial studies
This single-arm interventional protocol delivers ultra-hypofractionated stereotactic radiotherapy to patients with primary retroperitoneal or infra-peritoneal soft tissue sarcoma prior to surgical resection. Radiation is planned so all known disease can be included safely within a single treatment field, and strict organ-function and performance-status criteria must be met for enrollment. The trial's primary focus is feasibility and peri-operative complications following the condensed preoperative radiation schedule. The study is conducted at the Radiotherapy Department of the Cancer Hospital, Chinese Academy of Medical Sciences in Beijing.
Who should consider this trial
Good fit: Adults with primary retroperitoneal or pelvic soft tissue sarcoma that can be encompassed within one radiation field, who have good performance status (ECOG 0–2), acceptable organ function, and none of the excluded histologic subtypes.
Not a fit: Patients with excluded histologies (GIST, rhabdomyosarcoma, PNET/small-round-cell sarcomas, osteosarcoma, chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma), tumor extension through the sciatic notch or diaphragm, or inadequate organ function or poor performance/ASA scores are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could shorten preoperative treatment time while maintaining safe surgical outcomes and acceptable complication rates.
How similar studies have performed: Ultra-hypofractionated preoperative radiation for retroperitoneal sarcoma is relatively novel with limited direct evidence, though small series and analogous SABR approaches in other sarcoma and abdominal tumors have shown encouraging feasibility and safety signals.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Beijing, Beijing Municipality
- Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Ning-Ning Lu — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Ning-Ning Lu
- Email: Ning-Ning.Lu@hotmail.com
- Phone: +868611804268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.