Pancreas CancerPhase 3NEOPACNCT01521702
NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer
A Phase 3 study testing Neoadjuvant chemotherapy and surgery and Adjuvant chemotherapy in people with Pancreas Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy). This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Neoadjuvant chemotherapy and surgery and Adjuvant chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Feb 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
- T1-3, Nx, M0 (UICC 6th version, 2002)
- infiltration of the portal vein (<180°) is not an exclusion criterion
- cytologic or histologic confirmation of adenocarcinoma
- age >18 years
- written informed consent
Who cannot join
- contraindication for Whipple procedure
- an infiltration >180° of the portal vein
- abutment of the tumor to the superior mesenteric artery
- infiltration of the superior mesenteric artery or the celiac trunk
- chronic neuropathy > grade 2
- WHO performance score >2
Show all 12Show fewer
- uncorrectable cholestasis (bilirubin > 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)
- female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms)
- pregnant or lactating women
- mental or organic disorders which could interfere with giving informed consent or receiving treatments
- Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer
- percutaneous biopsy of the primary tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study
The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).
This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.
- Conditions
- Pancreas Cancer
- Being tested
- Neoadjuvant chemotherapy, surgery and Adjuvant chemotherapy
- Keywords
- adenocarcinoma, pancreatic head
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapyDrug
four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,
surgery and Adjuvant chemotherapyProcedure or surgery
surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | After initial staging laparoscopy, Neoadjuvant chemotherapy consists of four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, modified from the Louvet protocol11). Receives: Drug: Neoadjuvant chemotherapy |
| surgery | Active comparator | surgery Receives: Procedure: surgery and Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).
Measured: from date of randomization until date of progression, assessed up to 5 years
Secondary outcomes (3)
histology
histological response,
Measured: at 6 months
overall survival
time from date of inclusion to date of death
Measured: From date of randomization until date of death, assessed up to 5 years
complication
complication rates after surgery,
Measured: until 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc RAOUL, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521702
- Sponsor's protocol ID
- NEOPAC / IPC 2011-002
- Acronym
- NEOPAC
- Status last verified
- Mar 2015
- First submitted
- 22 Dec 2011
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study
- ClinicalTrials.gov ID
- NCT01521702
- Acronym / sponsor ID
- NEOPAC / NEOPAC / IPC 2011-002
- Conditions
- Pancreas Cancer
- Keywords
- adenocarcinoma, pancreatic head
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 31 Jan 2012 (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.
The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).
This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Drug: Neoadjuvant chemotherapyAfter initial staging laparoscopy, Neoadjuvant chemotherapy consists of four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, modified from the Louvet protocol11). |
| surgery | Active comparator | Procedure: surgery and Adjuvant chemotherapysurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
- T1-3, Nx, M0 (UICC 6th version, 2002)
- infiltration of the portal vein (<180°) is not an exclusion criterion
- cytologic or histologic confirmation of adenocarcinoma
- age >18 years
Key exclusion criteria (12 listed)
- contraindication for Whipple procedure
- an infiltration >180° of the portal vein
- abutment of the tumor to the superior mesenteric artery
- infiltration of the superior mesenteric artery or the celiac trunk
- chronic neuropathy > grade 2
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 |
|---|---|---|
| Neoadjuvant chemotherapyfour bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, | Drug | Neoadjuvant chemotherapy |
| surgery and Adjuvant chemotherapysurgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks. | Procedure or surgery | surgery |
Primary outcome
progression-free survival
Time frame: from date of randomization until date of progression, assessed up to 5 years
period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).
3 secondary outcomes
histology
Time frame: at 6 months
overall survival
Time frame: From date of randomization until date of death, assessed up to 5 years
complication
Time frame: until 6 months
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 20 Mar 2015.
- 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 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 3 study testing Neoadjuvant chemotherapy and surgery and Adjuvant chemotherapy in people with Pancreas Cancer, 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 6 inclusion and 12 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 20 Mar 2015. 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 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?
progression-free survival (time frame: from date of randomization until date of progression, assessed up to 5 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 20 Mar 2015.