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ClinicalTrials.gov ID

NCT07575724

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

3,300Estimated

Last Update Posted

Jul 14, 2026Actual

Start Date

Dec 1, 2026Estimated

Primary Completion Date

Dec 1, 2031Estimated

Completion Date

Dec 1, 2033Estimated

Official Title

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

Brief Summary

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.

• Primary
• Sarcoma

• biopsy tract resection
• biopsy tract non-resection

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of primary bone or soft tissue sarcoma of the extremities (or highly suspected sarcoma);
2. Candidate for limb-sparing surgery and capable of en-bloc resection;
3. Age ≥ 5 years;
4. ECOG performance status 0-2;
5. Able to understand and sign informed consent.

Exclusion Criteria:

1. Presence of distant metastasis (e.g., lung, bone, or other sites) or unresectable skip lesions;
2. Patients deemed, based on preoperative multidisciplinary team (MDT) evaluation, unlikely to achieve adequate surgical margins and therefore only eligible for debulking or palliative surgery;
3. Patients with inconclusive needle biopsy results requiring open biopsy for definitive diagnosis;
4. Patients requiring amputation;
5. Patients who have received prior treatment for the tumor at non-participating centers;
6. Patients with an expected survival of less than 2 years;
7. Patients in whom the biopsy tract completely lies within the planned tumor resection field;
8. Patients who refuse to provide written informed consent.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

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