NCT07575724Not yet recruitingPhase 2
Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma
Comparison of the Effects of Needle Biopsy Tract Resection and Non-resection on Recurrence Rate in Patients With Primary Extremity Sarcoma: Study Protocol of a Randomized, Non-inferior Clinical Trial
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
This randomized, non-inferiority clinical trial aims to evaluate whether non-resection of needle biopsy tract is non-inferior to routine biopsy tract resection in terms of local recurrence in patients with primary extremity musculoskeletal sarcoma undergoing en-bloc surgical treatment. Biopsy tract resection is traditionally recommended to reduce the risk of tumor seeding; however, its benefit in reducing recurrence has not been definitively demonstrated, particularly when core needle biopsy is widely used. Also, avoiding biopsy tract resection may preserve uninvolved tissue without compromising oncologic safety. The primary objective of this study is to compare local recurrence rates between patients who undergo biopsy tract resection and those who do not. Secondary objectives include comparisons of surgical complications, functional outcomes, overall survival, and progression-free survival.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 3300 (estimated)
- First submitted
- 2 Apr 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Dec 2031
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07575724
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 3300
- From 1 Dec 2026 to the primary completion date, 1 Dec 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients deemed, based on preoperative multidisciplinary team (MDT) evaluation, unlikely to achieve adequate surgical margins and therefore only eligible for debulking or palliative surgery;
- Patients who have received prior treatment for the tumor at non-participating centers;
- Patients in whom the biopsy tract completely lies within the planned tumor resection field;
Other
- Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions;
- Patients with inconclusive needle biopsy results requiring open biopsy for definitive diagnosis;
- Patients requiring amputation;
- Patients with an expected survival of less than 2 years;
- Patients who refuse to provide written informed consent.
Who the study is looking for
- Histologically confirmed diagnosis of primary bone or soft tissue sarcoma of the extremities (or highly suspected sarcoma);
- Candidate for limb-sparing surgery and capable of en-bloc resection;
- Age ≥ 5 years;
- ECOG performance status 0-2;
- Able to understand and sign informed consent.
Age in the registry: 5 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hangzhou Third People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.