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Solid TumorPICCHESTNCT06541301

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

A study testing PICC-port and Chest-port in people with Solid Tumor, run by European Institute of Oncology at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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"). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
PICC-port and Chest-port
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
852 participants
Where
3 sitesItaly
Study dates
Dec 2024to Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Roberto Biffi, MD contact

+39 02 57489710

roberto.biffi@ieo.it

Italy3 sites

  • CRO (Centro di Riferimento Oncologico)

    Aviano, 33081

    Fabrizio Brescia, 347 877 87 16, fabrizio.brescia@cro.it

  • Ospedale Careggi

    Florence, 50134

    Fulvio Pinelli, 349 050 42 97, fulvio.pinelli@unifi.it

  • European Institute of Oncology

    Milan, 20141

    Roberto Biffi, MD, +39 02 57489710, roberto.biffi@ieo.it

Other trials in Italy

About this study

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.

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.

Read the 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.

Conditions
Solid Tumor
Being tested
PICC-port, Chest-port
Keywords
Solid Tumor, Chest-ports, Peripherally Inserted Central Catheters-ports

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PICC-portDevice

    Implantation of a PICC-port device by a dedicated PICC team member following predefined evidence-based international guidelines and protocols

  • Chest-portDevice

    Implantation of a Chest-port device by expert physicians or certified expert nurses, following predefined evidence-based international guidelines and protocols

Study groups in NCT06541301
Study groupRoleWhat they receive
PICC-port armExperimentalImplantation of a PICC-port device
Receives: Device: PICC-port
Chest-port armActive comparatorImplantation of a Chest-port device
Receives: Device: Chest-port

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of device failures

    Number of unscheduled removal of the device due to complications

    Measured: 6 months

Secondary outcomes (1)

  1. Incidence of adverse events associated to device

    Number of adverse events associated with the implantation and use of the device that do not necessitate its removal

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2024
  2. Study startDec 2024 (estimated)
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, multicenter, open-label, non-inferiority clinical trial
Masking
None (open label)
Enrolment
852 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06541301
Sponsor's protocol ID
L2-113
Acronym
PICCHEST
Status last verified
Jul 2024
First submitted
2 Aug 2024
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gallieni M, Pittiruti M, Biffi R. Vascular access in oncology patients. CA Cancer J Clin. 2008 Nov-Dec;58(6):323-46. doi: 10.3322/CA.2008.0015. Epub 2008 Oct 29.

    PubMed 18971486

  • Biffi R, Pozzi S, Bonomo G, Della Vigna P, Monfardini L, Radice D, Rotmensz N, Zampino MG, Fazio N, Orsi F. Cost effectiveness of different central venous approaches for port placement and use in adult oncology patients: evidence from a randomized three-arm trial. Ann Surg Oncol. 2014 Nov;21(12):3725-31. doi: 10.1245/s10434-014-3784-5. Epub 2014 May 20.

    PubMed 24841352

  • Biffi R, Toro A, Pozzi S, Di Carlo I. Totally implantable vascular access devices 30 years after the first procedure. What has changed and what is still unsolved? Support Care Cancer. 2014 Jun;22(6):1705-14. doi: 10.1007/s00520-014-2208-1.

    PubMed 24659216

  • Bertoglio S, Cafiero F, Meszaros P, Varaldo E, Blondeaux E, Molinelli C, Minuto M. PICC-PORT totally implantable vascular access device in breast cancer patients undergoing chemotherapy. J Vasc Access. 2020 Jul;21(4):460-466. doi: 10.1177/1129729819884482. Epub 2019 Nov 1.

    PubMed 31674857

  • Bertoglio S, Annetta MG, Brescia F, Emoli A, Fabiani F, Fino M, Merlicco D, Musaro A, Orlandi M, Parisella L, Pinelli F, Reina S, Selmi V, Solari N, Tricarico F, Pittiruti M. A multicenter retrospective study on 4480 implanted PICC-ports: A GAVeCeLT project. J Vasc Access. 2022 Jan 17:11297298211067683. doi: 10.1177/11297298211067683. Online ahead of print.

    PubMed 35034480

  • Nickel B, Gorski L, Kleidon T, Kyes A, DeVries M, Keogh S, Meyer B, Sarver MJ, Crickman R, Ong J, Clare S, Hagle ME. Infusion Therapy Standards of Practice, 9th Edition. J Infus Nurs. 2024 Jan-Feb 01;47(1S Suppl 1):S1-S285. doi: 10.1097/NAN.0000000000000532. No abstract available.

    PubMed 38211609

  • Li G, Zhang Y, Ma H, Zheng J. Arm port vs chest port: a systematic review and meta-analysis. Cancer Manag Res. 2019 Jul 3;11:6099-6112. doi: 10.2147/CMAR.S205988. eCollection 2019.

    PubMed 31308748

  • Liu Y, Li LL, Xu L, Feng DD, Cao Y, Mao XY, Zheng J, Jin F, Chen B. Comparison between Arm Port and Chest Port for Optimal Vascular Access Port in Patients with Breast Cancer: A Systematic Review and Meta-Analysis. Biomed Res Int. 2020 Feb 13;2020:9082924. doi: 10.1155/2020/9082924. eCollection 2020.

    PubMed 32104708

  • Annetta MG, Bertoglio S, Biffi R, Brescia F, Giarretta I, Greca A, Panocchia N, Passaro G, Perna F, Pinelli F, Pittiruti M, Prisco D, Sanna T, Scoppettuolo G. Management of antithrombotic treatment and bleeding disorders in patients requiring venous access devices: A systematic review and a GAVeCeLT consensus statement. J Vasc Access. 2022 Jul;23(4):660-671. doi: 10.1177/11297298211072407. Epub 2022 May 9.

    PubMed 35533088

  • Biffi R, Orsi F, Pozzi S, Pace U, Bonomo G, Monfardini L, Della Vigna P, Rotmensz N, Radice D, Zampino MG, Fazio N, de Braud F, Andreoni B, Goldhirsch A. Best choice of central venous insertion site for the prevention of catheter-related complications in adult patients who need cancer therapy: a randomized trial. Ann Oncol. 2009 May;20(5):935-40. doi: 10.1093/annonc/mdn701. Epub 2009 Jan 29.

    PubMed 19179550

Questions about this trial

What is this clinical trial studying?

A study testing PICC-port and Chest-port in people with Solid Tumor, run by European Institute of Oncology at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Roberto Biffi, MD (+39 02 57489710, roberto.biffi@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of device failures (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06541301, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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