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Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

Status: Recruiting
Phase: Phase 3
Diagnosis: Sarcoma
NCT ID: NCT01479283 (View complete trial on
DFCI Protocol ID: 13-222


The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial is the first ever international multi-center randomized controlled trial in bone cancer surgery. In order to avoid amputation for bone cancer in the leg, complex limb-saving operations are performed. However, infections with devastating complications following surgery are common. Surgeons from across the world will randomize patients to receive either short- or long-duration antibiotic regimens after surgery with the goal of identifying the best regimen to reduce these infections.


Conducting Institutions:
Beth-Israel Deaconess Medical Center, Children's Hospital Boston, Massachusetts General Hospital

Overall PI:
Megan Anderson, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:

Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - primary malignant or aggressive benign bone tumors of the lower extremity, or soft-tissue sarcomas which have invaded the bone; and - treatment by surgical excision and endoprosthetic replacement. Exclusion Criteria: - current known Methicillin-resistant Staphylococcus Aureus (MRSA) colonization; - current known Vancomycin Resistant Enterococcus (VRE) colonization; - documented anaphylaxis or angioedema to penicillin or cefazolin (Ancef); - prior surgery within the surgical field of the affected limb (excluding biopsy); - prior local infection within the surgical field of the affected limb; - current known immunologically-deficient disease conditions (not including recent chemotherapy); - known renal insufficiency with estimated creatinine clearance (eGRF) of less than 54 mL/min; - reconstruction to include allograft; - enrolled in a competing study; and - weight of less than or equal to 45 kg (for sites using cefuroxime only).
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