Solid Tumor, AdultPACPAC-EPOCNCT03410121
Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy
A study testing IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108. and Vital Port®Minititanium in people with Solid Tumor, Adult and Chemotherapy Treatment, run by Center Eugene Marquis at 1 site in France.
Trial summary
The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Chemotherapy Treatment, Advanced or Metastasis Stage
- What is being tested?
- IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108. and Vital Port®Minititanium
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2018to 17 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with solid tumors at an Advanced or metastasis stage requiring placement of implantable catheter for intravenous chemotherapy treatment
- Older than 18 years
- Express signed consent
Who cannot join
- Life expectancy less than 12 months assessed by investigator
- Infection or uncontrolled suspected infection
- Medical contraindication to port implantation by catheter in thoracic or humeral location
- Pregnant or lactating women
- Abnormal coagulation
- Immunosuppressed patients (for example known hepatitis B or C, or known positive Human Immunodeficiency Virus due to the spreading risk)
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- Patient not affiliated to the French social security
- Access time to the humeral or thoracic port placement higher than 15 days (from the randomization theoretical date)
- Protected Adult or adult deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study Comparing Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Intravenous Chemotherapy
The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed.
Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible.
Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.
- Being tested
- IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108., Vital Port®Minititanium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.Device
Implantation of intravenous medical device in thoracic location
Vital Port®MinititaniumDevice
Implantation of intravenous medical device in humeral location
| Study group | Role | What they receive |
|---|---|---|
| Standard 1 : Thoracic location | Other | The intervention is characterized by the randomization into thoracic arm which means that patients will have an implantable Venous Access Device implanted into thoracic location Receives: Device: IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108. |
| Standard 2 : Humeral location | Other | The intervention is characterized by the randomization into humeral arm which means that patients will have an implantable Venous Access Device implanted into humeral location Receives: Device: Vital Port®Minititanium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications related to Implantable Venous Access Device
Number of complications that will be recorded by medical oncologist
Measured: 3 months after medical device placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start9 Mar 2018
- Primary completion26 Dec 2023
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence CROUZET, MD, Principal investigator, Centre Eugène Marquis, Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410121
- Sponsor's protocol ID
- 2016-4-46-002
- Acronym
- PACPAC-EPOC
- Status last verified
- Jul 2025
- First submitted
- 18 Jan 2018
- Last updated
- 5 Aug 2025
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study Comparing Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Intravenous Chemotherapy
- ClinicalTrials.gov ID
- NCT03410121
- Acronym / sponsor ID
- PACPAC-EPOC / 2016-4-46-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 25 Jan 2018 (actual)
- 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.
The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed.
Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible.
Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard 1 : Thoracic location | Other | Device: IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.The intervention is characterized by the randomization into thoracic arm which means that patients will have an implantable Venous Access Device implanted into thoracic location |
| Standard 2 : Humeral location | Other | Device: Vital Port®MinititaniumThe intervention is characterized by the randomization into humeral arm which means that patients will have an implantable Venous Access Device implanted into humeral location |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with solid tumors at an Advanced or metastasis stage requiring placement of implantable catheter for intravenous chemotherapy treatment
- Older than 18 years
- Express signed consent
Key exclusion criteria (9 listed)
- Life expectancy less than 12 months assessed by investigator
- Infection or uncontrolled suspected infection
- Medical contraindication to port implantation by catheter in thoracic or humeral location
- Pregnant or lactating women
- Abnormal coagulation
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 |
|---|---|---|
| IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.Implantation of intravenous medical device in thoracic location | Device | Standard 1 : Thoracic location |
| Vital Port®MinititaniumImplantation of intravenous medical device in humeral location | Device | Standard 2 : Humeral location |
Primary outcome
Number of complications related to Implantable Venous Access Device
Time frame: 3 months after medical device placement
Number of complications that will be recorded by medical oncologist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- 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.
Laurence CROUZET, MD principal investigator
Centre Eugène Marquis, Rennes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108. and Vital Port®Minititanium in people with Solid Tumor, Adult and Chemotherapy Treatment, run by Center Eugene Marquis 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 5 Aug 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of complications related to Implantable Venous Access Device (time frame: 3 months after medical device placement). 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 Aug 2025.