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New treatment option for Soft Tissue Sarcoma
Official title Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
ClinicalTrials.gov ID: NCT05224934
What this study is testing
- What it's testing
- To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- metastatic disease
- Tumor was previously treated by radiotherapy
- Involvement of liver, pancreatic head or duodenum
See the full eligibility 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...
- 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
- metastatic disease
- Tumor was previously treated by radiotherapy
- Involvement of liver, pancreatic head or duodenum
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.