Electrochemotherapy in Musculoskeletal Tumors

Electrochemotherapy in Musculoskeletal Tumors: A Quantitative Assessment of Tumor Size Variations and Treatment-related Pain Reduction.

The study involves the enrollment of patients over 2 years of age with a diagnosis of musculoskeletal tumors and an indication for electrochemotherapy, treated at the Rizzoli Orthopaedic Institute in Bologna and followed during outpatient follow-up. Data will be collected from medical records, outpatient reports, and imaging studies including CT, X-ray, MRI, and/or PET.

For the retrospective part of the study, patients treated at the Rizzoli Orthopaedic Institute from 01/01/2024 to the date of approval of this study will be included. For the prospective part, patients meeting the inclusion criteria and treated from the study start date until 31/12/2030 will be enrolled.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Tumors

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40134
      • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include patients older than 2 years with a diagnosis of musculoskeletal tumors who are indicated for electrochemotherapy, treated at the Rizzoli Orthopaedic Institute in Bologna and followed during outpatient follow-up. Data will be collected from medical records, outpatient reports, and imaging studies (CT, X-ray, MRI, and/or PET).

The retrospective part will include patients treated at the Rizzoli Orthopaedic Institute from January 1, 2024, to the date of study approval.

The prospective part will enroll patients meeting the inclusion criteria who will be treated from the study start date until December 31, 2030.

Description

Inclusion Criteria:

• Patients of both sexes with a histological diagnosis of a primary musculoskeletal tumor, either benign or malignant, located outside the abdominal cavity (trunk and limbs)

• Indication for electrochemotherapy due to one of the following conditions:

  1. Clinical conditions contraindicating surgery
  2. Tumor not surgically resectable

• Patients treated with electrochemotherapy at the Rizzoli Orthopaedic Institute:

  1. From 01/01/2024 to the date of study approval for the retrospective phase
  2. From the date of study approval to 12/31/2030 for the prospective phase
• Retrospectively treated patients with a minimum follow-up of at least 3 months
• Age ≥ 2 years at the time of treatment
• Availability of clinical and instrumental data

Exclusion Criteria:

• Failure to meet at least one of the inclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor size will be assessed using CT, MRI, X-ray, and/or PET imaging. Tumor size will be defined as the longest diameter of the target lesion (mm).	3, 6, and 12 months after electrochemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in pain intensity measured by the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate worse pain, at 3, 6, and 12 months after electrochemotherapy.Number of participants with treatment-related adverse events	3, 6, and 12 months after treatment

Collaborators and Investigators

• Sponsor: Costantino Errani

Publications and helpful links

General Publications

• Campanacci L, Cevolani L, De Terlizzi F, Saenz L, Ali N, Bianchi G, Donati DM. Electrochemotherapy Is Effective in the Treatment of Bone Metastases. Curr Oncol. 2022 Mar 4;29(3):1672-1682. doi: 10.3390/curroncol29030139.
• Cevolani L, Campanacci L, Staals EL, Dozza B, Bianchi G, De Terlizzi F, Donati DM. Is the association of electrochemotherapy and bone fixation rational in patients with bone metastasis? J Surg Oncol. 2023 Jul;128(1):125-133. doi: 10.1002/jso.27247. Epub 2023 Mar 26.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Estimated): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Bone Neoplasms
• Other Study ID Numbers: ELECTRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No