Clinical trial NCT06541301: PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Solid Tumor
Keywords: Solid Tumor
Chest-ports
Peripherally Inserted Central Catheters-ports
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, multicenter, open-label, non-inferiority clinical trial
Primary purpose: OTHER

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.

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 outcomes:
measure: Incidence of device failures
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of adverse events associated to device
timeFrame: 6 months
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: CRO (Centro di Riferimento Oncologico)
city: Florence
country: Italy
facility: Ospedale Careggi
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Istitute of Oncology
name: Roberto Biffi, MD
role: PRINCIPAL_INVESTIGATOR
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