Clinical trial · Interventional
Iterative PICC Placement Versus Long Term Device
A Randomized, Multicentre, Comparative Phase III Study of Catheter-related Complications of an Iterative PICC Placement vs a Long-term PAC in Patients With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Changes of the standard adjuvant treatment which does not allow an iterative PICC placement
Summary
Brief summary (as posted)
Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly medical devices used for the administration of chemotherapy. Placement of these devices via central venous access is sometimes responsible for complications. The incidence of these complications is correlated with the device holding time. A strategy of iterative PICC placement could significantly reduce these complications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iterative PICC placement | Procedure | — | UNRESOLVED |
| Long term PAC placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Iterative PICC placement
- description
- New PICC placement at each chemotherapy cycle (removed after treatment administration)
- interventionNames
- Procedure: Iterative PICC placement
- type
- ACTIVE_COMPARATOR
- label
- Long term implantable device
- description
- Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study
- interventionNames
- Procedure: Long term PAC placement
Primary outcomes (1)
- measure
- Compare complication rate for iterative placement (PICC) versus long term placement (PAC).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women older than 18 years old; * Breast cancer diagnosis histologically proven , for any histological subtypes; * 4 or 6 indication of neoadjuvant or adjuvant chemotherapy; according to hormonal status and HER2 of the tumors, the patient may be treated concomitantly with hormone therapy and / or trastuzumab; Nota Bene: treatment protocol adopted will imperatively be administered in 3-week cycles. * Central venous access indication; * Ability to understand and willingness to comply with the study monitoring; * Affiliated to the French social security system; * Informed Consent dated and signed, indicating that the patient has been informed of all pertinent aspects of the study before inclusion. Exclusion Criteria: * Any contraindication for placement of a central venous catheter ( hemostasis disorders , active infection treated with antibiotics , ...); * Patient who can't stop anti -vitamin K treatment ( AVK ) ( a relay by Heparin Low Molecular Weight (LMWH) is possible); * History of central access, regardless of the indication; * Any active disease other than cancer pathology , requiring repeated administration of intravenous therapy ; * Patient deprived of liberty; * Not monitoring for social, geographical, psychological or family reason.
References
Publications (0)
Data not yet available