Pancreatic NeoplasmsPhase 2NCT00191568
Gemcitabine, Oxaliplatin and Radiotherapy in Treating Patients With Completely Resected Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Oxaliplatin and Radiotherapy in people with Pancreatic Neoplasms, run by Eli Lilly and Company at 6 sites in France.
Trial summary
A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Gemcitabine, Oxaliplatin and Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2002to May 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed adenocarcinoma of the pancreas
- Patient have undergone a potentially curative resection
- No previous irradiation to the planned field
- Negative pregnancy test for child bearing women
Who cannot join
- Non-adenocarcinoma pancreatic cancer
- Treatment with any drug within the last 30 days that has not received regulatory approval.
- Serious systemic disorder
- Metastatic disease
- Pregnancy, breast feeding
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Grenoble
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Lyon
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Marseille
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Montpellier
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Paris
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Pierre-Bénite
About this study
Official title: A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma
A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Gemcitabine, Oxaliplatin, Radiotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
OxaliplatinDrug
RadiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study
Secondary outcomes (1)
To assess overall survival at the end of the 24 months follow up period;To assess acute and late toxicity (every month for the first 3 months and then every three months for 24 months after treatment discontinuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2002
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191568
- Sponsor's protocol ID
- 6866
- Other IDs
- B9E-MC-S298
- Status last verified
- Oct 2007
- First submitted
- 12 Sep 2005
- Last updated
- 19 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00191568
- Acronym / sponsor ID
- 6866
- Conditions
- Pancreatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- May 2007 (actual)
- First posted
- 19 Sep 2005 (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.
A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed adenocarcinoma of the pancreas
- Patient have undergone a potentially curative resection
- No previous irradiation to the planned field
- Negative pregnancy test for child bearing women
Key exclusion criteria (5 listed)
- Non-adenocarcinoma pancreatic cancer
- Treatment with any drug within the last 30 days that has not received regulatory approval.
- Serious systemic disorder
- Metastatic disease
- Pregnancy, breast feeding
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 |
|---|---|---|
| Gemcitabine | Drug | – |
| Oxaliplatin | Drug | – |
| Radiotherapy | Procedure or surgery | – |
Primary outcome
To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study
1 secondary outcome
To assess overall survival at the end of the 24 months follow up period;To assess acute and late toxicity (every month for the first 3 months and then every three months for 24 months after treatment discontinuation)
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 19 Oct 2007.
- Lilly Clinical Trial RegistryLink 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.
1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5hours, EST) study director
Eli Lilly and Company
6 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 Gemcitabine, Oxaliplatin and Radiotherapy in people with Pancreatic Neoplasms, run by Eli Lilly and Company at 6 sites 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 4 inclusion and 5 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 19 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study. 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 19 Oct 2007.