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ClinicalTrials.gov ID

NCT06541301

Lead Sponsor

European Institute of OncologyOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

852Estimated

Last Update Posted

Nov 19, 2024Actual

Start Date

Dec 2024Estimated

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2026Estimated

Official Title

PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients Affected by Solid Tumors. A Prospective, Randomized Multicentric, Non Inferiority, Phase III Trial.

Brief Summary

Central venous access devices are extensively used in oncology patients. The current standard is represented by devices inserted by direct ultrasound guided cannulation of deep veins of supra/infraclavicular area with a reservoir placed in a subcutaneous pocket of the upper chest wall ("chest-ports"). More recently, PICC (Peripherally Inserted Central Catheters)-ports have been proposed as an alternative to chest-ports.

Aim of this study is to demonstrate the non-inferiority of PICC ports compared to thoracic ports in terms of efficacy and safety.

Detailed Description

Central venous access devices are extensively used in oncology patients who need safe deliverance of chemotherapeutic agents and drugs, transfusion of blood and blood products, and performance of laboratory tests, in solid as well as hematologic malignancies. These devices are mostly inserted by direct ultrasound guided cannulation of deep veins of supra/infraclavicular area and the reservoir is placed in a subcutaneous pocket of the upper chest wall ("chest-ports"). More recently, PICC (Peripherally Inserted Central Catheters)-ports have been proposed as a safe and effective alternative to chest-ports, claiming lower invasiveness, easier insertion and better patients' compliance. In PICC-ports a small reservoir is placed in a subcutaneous pocket located in the mid-third of the upper arm.

Since these feelings are currently based only on limited retrospective studies, aim of this randomized multicenter trial is to demonstrate the non-inferiority of PICC ports (experimental arm) compared to thoracic ports (control arm, as the current reference standard) in terms of efficacy and safety.

• Solid Tumor

• PICC-port
• Chest-port

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• ≥ 18 Age ≤ 75 yrs
• Histologic diagnosis of a solid tumour
• Need for intravenous , long term (> 3 months), intermittent chemotherapy (either adjuvant or palliative)
• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2

Exclusion Criteria:

• Active infections
• Coagulopathy, defined as platelet count < 50,000/μL and/or Prothrombin time (PT)/International Normalized Ratio (INR) > 1.5
• Chronic severe renal failure, stage 3b-4-5 or imminent need for a dialysis fistula
• Any conditions contraindicating chemotherapy treatments, as valued by treating oncologist
• Life expectancy < 6 months, as valued by treating oncologist
• Inability to give an informed consent and/or history of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

European Institute of OncologyOTHER

fulvio.pinelli@unifi.it349 050 42 97

roberto.biffi@ieo.it+39 02 57489710