Adenocarcinoma of Head of PancreasPhase 2PROPACNCT02487836
Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas
A Phase 2 study testing Type WallFlex or Evolution biliary, stent system in people with Adenocarcinoma of Head of Pancreas, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenocarcinoma of Head of Pancreas
- What is being tested?
- Type WallFlex or Evolution biliary, stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 2
- 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
- Patient aged > 18 ans and ≤ 75 ans
- Suspicion of adenocarcinoma of the head of the pancreas leading to the placement of a biliary stent
- Either metastatic or "borderline" (at the limit of resectability) or locally advanced
- PS = 0 or 1
- Hematological laboratory parameters (ANC ≥ 1.5 10 9 / l (/ mm3), platelets ≥ 100 10 9 / l (G / L)) and kidney (calculated creatinin clearance> 60 ml / min)
- Jaundice (bilirubin> 20 mmol / L) by compressing the lower part of the bile duct (dilatation of the extrahepatic bile duct)
- Written informed Consent
- Affiliation to social security
Who cannot join
- Pregnant or lactating woman or without contraception (for child bearing potential women)
- Patient deprived of liberty or under supervision of a guardian
- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
- Contra-indication for study procedure
- Predictable technical impossibility to position a stent endoscopically (prior upper GI surgery)
- Life expectancy assumed less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas
For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt.
Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability).
Read more
However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN.
In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder).
It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.
- Conditions
- Adenocarcinoma of Head of Pancreas
- Being tested
- Type WallFlex or Evolution biliary, stent system
- Keywords
- Laying of the biliary stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type WallFlex or Evolution biliary, stent systemDevice
Laying of a stent biliary
| Study group | Role | What they receive |
|---|---|---|
| First attempt stenting (T0 = date of the first act) | Other | Efficacy of laying of a biliary stent for chemotherapy realization Receives: Device: Type WallFlex or Evolution biliary, stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percentage of patients who, at Day 28 after the first attempt stenting (T0 = date of the first act), has received or is able to receive FOLFIRINOX.
Measured: At day 28 after the laying of the biliary stent
Secondary outcomes (3)
Rate of biliary infection starting within 3 months after insertion of the prosthesis
Measured: From the laying of the biliary stent to 3 months follow up
Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts)
Measured: From the laying of the biliary stent to 3 months follow up
Complication (s) other (s) (bleeding, perforation, ...) possibly attached (s) endoscopic treatment within 3 months.
Measured: From the laying of the biliary stent to 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of Head of PancreasStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc RAOUL, MD, PHD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487836
- Sponsor's protocol ID
- PROPAC-IPC 2012 006
- Acronym
- PROPAC
- Status last verified
- Oct 2013
- First submitted
- 25 Jun 2015
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas
- ClinicalTrials.gov ID
- NCT02487836
- Acronym / sponsor ID
- PROPAC / PROPAC-IPC 2012 006
- Conditions
- Adenocarcinoma of Head of Pancreas
- Keywords
- Laying of the biliary stent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Jul 2015 (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.
For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt.
Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability).
However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN.
In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder).
It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First attempt stenting (T0 = date of the first act) | Other | Device: Type WallFlex or Evolution biliary, stent systemEfficacy of laying of a biliary stent for chemotherapy realization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient aged > 18 ans and ≤ 75 ans
- Suspicion of adenocarcinoma of the head of the pancreas leading to the placement of a biliary stent
- Either metastatic or "borderline" (at the limit of resectability) or locally advanced
- PS = 0 or 1
- Hematological laboratory parameters (ANC ≥ 1.5 10 9 / l (/ mm3), platelets ≥ 100 10 9 / l (G / L)) and kidney (calculated creatinin clearance> 60 ml / min)
Key exclusion criteria (6 listed)
- Pregnant or lactating woman or without contraception (for child bearing potential women)
- Patient deprived of liberty or under supervision of a guardian
- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
- Contra-indication for study procedure
- Predictable technical impossibility to position a stent endoscopically (prior upper GI surgery)
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 |
|---|---|---|
| Type WallFlex or Evolution biliary, stent systemLaying of a stent biliary | Device | First attempt stenting (T0 = date of the first act) |
Primary outcome
Determine the percentage of patients who, at Day 28 after the first attempt stenting (T0 = date of the first act), has received or is able to receive FOLFIRINOX.
Time frame: At day 28 after the laying of the biliary stent
3 secondary outcomes
Rate of biliary infection starting within 3 months after insertion of the prosthesis
Time frame: From the laying of the biliary stent to 3 months follow up
Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts)
Time frame: From the laying of the biliary stent to 3 months follow up
Complication (s) other (s) (bleeding, perforation, ...) possibly attached (s) endoscopic treatment within 3 months.
Time frame: From the laying of the biliary stent to 3 months follow up
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 26 Feb 2016.
- official web site of the sponsorLink provided by the sponsor.
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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.
Jean-Luc RAOUL, MD, PHD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Type WallFlex or Evolution biliary, stent system in people with Adenocarcinoma of Head of Pancreas, run by Institut Paoli-Calmettes 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 8 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: finished, as of the sponsor's last update on 26 Feb 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Determine the percentage of patients who, at Day 28 after the first attempt stenting (T0 = date of the first act), has received or is able to receive FOLFIRINOX. (time frame: At day 28 after the laying of the biliary stent). 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 26 Feb 2016.