Not Yet RecruitingNot Applicable

PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients

Italy852 participantsStarted 2024-12

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of device failures

Timeframe: 6 months

Trial details

NCT IDNCT06541301

SponsorEuropean Institute of Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02

Contact for this trial

Roberto Biffi, MD

+39 02 57489710 roberto.biffi@ieo.it

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