Breast CancerPhase 3PICC One DayNCT02784730
Iterative PICC Placement Versus Long Term Device
A Phase 3 study testing Iterative PICC placement and Long term PAC placement in people with Breast Cancer, run by Centre Leon Berard at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Iterative PICC placement and Long term PAC placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2018to 10 Jan 2018
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Breast Cancer
- Being tested
- Iterative PICC placement, Long term PAC placement
- Keywords
- breast cancer, chemotherapy, peripherally inserted central catheter, implantable device, randomized controlled trial, iterative placement, Catheterization, Central Venous
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iterative PICC placementProcedure or surgery
Intervention is the catheterisation strategy (not the device)
Long term PAC placementProcedure or surgery
Intervention is the catheterisation strategy (not the device)
| Study group | Role | What they receive |
|---|---|---|
| Iterative PICC placement | Experimental | New PICC placement at each chemotherapy cycle (removed after treatment administration) Receives: Procedure: Iterative PICC placement |
| Long term implantable device | Active comparator | Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study Receives: Procedure: Long term PAC placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare complication rate for iterative placement (PICC) versus long term placement (PAC).
Complication rate will be defined by the proportion of patients with at least one of the following complications from the date of randomization to the end of the study:
pneumothorax , hemothorax ,veinous thrombosis, migration or expulsion of the device, fissure or rupture of the catheter, catheter obstruction, extravasation.
Measured: 6 months after randomization
Secondary outcomes (4)
Success rate for each strategy
Success rate will be determined with the proportion of patients in whom the allocation strategy was conducted until the end of the last cycle of chemotherapy
Measured: 6 months after randomization
Description of failure causes for each strategy
Causes of failures will be described
Measured: 6 months after randomization
Level of pain for each strategy
Level of pain will be assessed with the verbal scale rated from 0 to 10
Measured: At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1
Quality of Life in both arms
Quality of Life will be assessed with the EQ-5D questionnaire
Measured: At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start10 Jan 2018
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Why it stopped: Changes of the standard adjuvant treatment which does not allow an iterative PICC placement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, C. R. Bard
- Responsible party
- Sponsor
- Investigators
- Hervé ROSAY, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784730
- Sponsor's protocol ID
- PICC One Day 01 (ET15-123)
- Other IDs
- 2015-A01822-47
- Acronym
- PICC One Day
- Status last verified
- Feb 2018
- First submitted
- 19 May 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02784730
- Acronym / sponsor ID
- PICC One Day / PICC One Day 01 (ET15-123)
- Conditions
- Breast Cancer
- Keywords
- breast cancer, chemotherapy, peripherally inserted central catheter, implantable device, randomized controlled trial, iterative placement, Catheterization, Central Venous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes of the standard adjuvant treatment which does not allow an iterative PICC placement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Ministry of Health, France, C. R. Bard
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iterative PICC placement | Experimental | Procedure: Iterative PICC placementNew PICC placement at each chemotherapy cycle (removed after treatment administration) |
| Long term implantable device | Active comparator | Procedure: Long term PAC placementPort-a-cath inserted prio first chemotherapy cycle and maintained throughout the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iterative PICC placementIntervention is the catheterisation strategy (not the device) | Procedure or surgery | Iterative PICC placement |
| Long term PAC placementIntervention is the catheterisation strategy (not the device) | Procedure or surgery | Long term implantable device |
Primary outcome
Compare complication rate for iterative placement (PICC) versus long term placement (PAC).
Time frame: 6 months after randomization
Complication rate will be defined by the proportion of patients with at least one of the following complications from the date of randomization to the end of the study: pneumothorax , hemothorax ,veinous thrombosis, migration or expulsion of the device, fissure or rupture of the catheter, catheter obstruction, extravasation.
4 secondary outcomes
Success rate for each strategy
Time frame: 6 months after randomization
Description of failure causes for each strategy
Time frame: 6 months after randomization
Level of pain for each strategy
Time frame: At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1
Quality of Life in both arms
Time frame: At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé ROSAY, MD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iterative PICC placement and Long term PAC placement in people with Breast Cancer, run by Centre Leon Berard at 1 site in France.
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 7 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: withdrawn, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare complication rate for iterative placement (PICC) versus long term placement (PAC). (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2018.