Pancreatic CancerPhase 2NCT01397019
Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours
A Phase 2 study testing Oxaliplatin, irinotecan, 5-FU & leucovorin in people with Pancreatic Cancer, run by Per Pfeiffer at 3 sites in Denmark.
Trial summary
Treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan \& 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Oxaliplatin, irinotecan, 5-FU & leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesDenmark
- Study dates
- Apr 2011to Feb 2018
- 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
- non-metastatic pancreatic cancer
- Performance status 0-1
- Bilirubin < 1.5 UNL
- Written informed consent
Who cannot join
- no prior abdominal radiotherapy
- no prior chemotherapy for pancratic cancer
- no severe comorbidity
- patients must be able to undergo potential abdominal surgery
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital
Aarhus, 8000
Herlev University Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
About this study
Official title: Chemotherapy for Patients With Locally Advanced Pancreatic Cancer With Additional Chemo-radiotherapy for Patients With Borderline Resectable Tumours
Treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan \& 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial borderline resectable tumors and improved overall survival for all patients.
Read the detailed description
Pancreatic cancer (PC) is the third most common gastrointestinal malignancy and one of the top ten leading causes of cancer deaths in the Western world. Patients with PC can be divided into three subgroups; resectable (rPC), locally advanced (LAPC) and metastatic (mPC). For patients with rPC surgery offers the best chance for long term survival. However it is estimated that only 20% of patients have rPC at the time of diagnosis. For patients with LACP, invasion of local large vessels is most often the cause for non-resectability. The median survival of these patients is between 6 to 12 months and long term survival in is extremely rare. The optimal treatment of LAPC is controversial. Treatment strategies vary between attempts to "downstage" the tumour to rPC, or treat the patients in a palliative setting only. Phase II studies and retrospective series have evaluated various treatments regimens and strategies including chemotherapy and radiotherapy (RT) alone or in combination - chemoradiotherapy (CRT). Results from these trials give no clear answer regarding the best treatment strategy. However, data from several studies shows that treatment of LAPC may result in shrinkage of the tumour, and thus potentially lead to a resection; also data suggests that CRT after chemotherapy improves treatment efficacy. Recent data from patients with mPC has show a combination of oxaliplatin, irinotecan and 5-FU (FOLFIRINOX) increases response rates from 10% to 30% and median survival to 11.1 months. The promising efficacy makes it natural to attempt this treatment in patients with LAPC.
- Conditions
- Pancreatic Cancer
- Being tested
- Oxaliplatin, irinotecan, 5-FU & leucovorin
- Keywords
- Pancreatic cancer, Chemotherapy, Chemoradiotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin, irinotecan, 5-FU & leucovorinDrug
FOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX | Experimental | Not described Receives: Drug: Oxaliplatin, irinotecan, 5-FU & leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year survival rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2016
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Pfeiffer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per Pfeiffer, Odense University Hospital
- Investigators
- Per Pfeiffer, Professor, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397019
- Sponsor's protocol ID
- DPSG 2010-01
- Status last verified
- Oct 2020
- First submitted
- 18 Jul 2011
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy for Patients With Locally Advanced Pancreatic Cancer With Additional Chemo-radiotherapy for Patients With Borderline Resectable Tumours
- ClinicalTrials.gov ID
- NCT01397019
- Acronym / sponsor ID
- DPSG 2010-01
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Chemotherapy, Chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Per PfeifferUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 19 Jul 2011 (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.
Treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan \& 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial borderline resectable tumors and improved overall survival for all patients.
Detailed description
Pancreatic cancer (PC) is the third most common gastrointestinal malignancy and one of the top ten leading causes of cancer deaths in the Western world. Patients with PC can be divided into three subgroups; resectable (rPC), locally advanced (LAPC) and metastatic (mPC). For patients with rPC surgery offers the best chance for long term survival. However it is estimated that only 20% of patients have rPC at the time of diagnosis. For patients with LACP, invasion of local large vessels is most often the cause for non-resectability. The median survival of these patients is between 6 to 12 months and long term survival in is extremely rare. The optimal treatment of LAPC is controversial. Treatment strategies vary between attempts to "downstage" the tumour to rPC, or treat the patients in a palliative setting only. Phase II studies and retrospective series have evaluated various treatments regimens and strategies including chemotherapy and radiotherapy (RT) alone or in combination - chemoradiotherapy (CRT). Results from these trials give no clear answer regarding the best treatment strategy. However, data from several studies shows that treatment of LAPC may result in shrinkage of the tumour, and thus potentially lead to a resection; also data suggests that CRT after chemotherapy improves treatment efficacy. Recent data from patients with mPC has show a combination of oxaliplatin, irinotecan and 5-FU (FOLFIRINOX) increases response rates from 10% to 30% and median survival to 11.1 months. The promising efficacy makes it natural to attempt this treatment in patients with LAPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRINOX | Experimental | Drug: Oxaliplatin, irinotecan, 5-FU & leucovorin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-metastatic pancreatic cancer
- Performance status 0-1
- Bilirubin < 1.5 UNL
- Written informed consent
Key exclusion criteria (4 listed)
- no prior abdominal radiotherapy
- no prior chemotherapy for pancratic cancer
- no severe comorbidity
- patients must be able to undergo potential abdominal 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 |
|---|---|---|
| Oxaliplatin, irinotecan, 5-FU & leucovorinFOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors | Drug | FOLFIRINOX |
Primary outcome
2 year survival rate
Time frame: 2 years
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 2 Nov 2020.
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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.
Per Pfeiffer, Professor principal investigator
Odense University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, irinotecan, 5-FU & leucovorin in people with Pancreatic Cancer, run by Per Pfeiffer at 3 sites in Denmark.
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 4 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 2 Nov 2020. 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 Denmark. 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?
2 year survival rate (time frame: 2 years). 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 2 Nov 2020.