NCT05224934 Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
| NCT ID | NCT05224934 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
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 * 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
Contact & Investigator
Ning-Ning Lu
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT05224934 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05224934 currently recruiting?
Yes, NCT05224934 is actively recruiting participants. Contact the research team at Ning-Ning.Lu@hotmail.com for enrollment information.
Where is the NCT05224934 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05224934 clinical trial?
NCT05224934 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Ning-Ning Lu at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 50 participants.