Pancreatic CancerNCT00322712
INST 0603C Patients With Unresectable/Metastatic Pancreatic Cancer Treated in the UNM Cancer
An observational study of Pancreatic Cancer, run by University of New Mexico at 1 site in United States.
Trial summary
Chart Review of patients with pancreatic cancer treated with combination of irinotecan, oxaliplatin and cetuximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2007
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients with unresectable/metastatic pancreatic cancer treated in the UNM Cancer Research and Treatment Center.
Who may be able to join
- Patients with unresectable/metastatic pancreatic cancer treated in the UNM Cancer Research and Treatment Center.
Who cannot join
- Not specified.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: INST 0603C Chart Review on Patients With Unresectable/Metastatic Pancreatic Cancer Treated in the UNM Cancer
Chart Review of patients with pancreatic cancer treated with combination of irinotecan, oxaliplatin and cetuximab.
Read the detailed description
Chart Review to describe the clinical outcomes in patients pancreatic cancer treated with combination of irinotecan, oxaliplatin and cetuximab.
- Conditions
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Death
Length of survival of patients treated with a combination of Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week.
Measured: From date of treatment until time of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2006
- Study completionJan 2007
Why it stopped: This is only a chart review. This is not a clinical trial and was inadvertently entered in the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fa-Chyi Lee, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322712
- Sponsor's protocol ID
- INST 0603C
- Status last verified
- Jan 2024
- First submitted
- 5 May 2006
- Last updated
- 5 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INST 0603C Chart Review on Patients With Unresectable/Metastatic Pancreatic Cancer Treated in the UNM Cancer
- ClinicalTrials.gov ID
- NCT00322712
- Acronym / sponsor ID
- INST 0603C
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This is only a chart review. This is not a clinical trial and was inadvertently entered in the system.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Sep 2006 (actual)
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 8 May 2006 (estimated)
- Results
- Posted 4 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chart Review of patients with pancreatic cancer treated with combination of irinotecan, oxaliplatin and cetuximab.
Detailed description
Chart Review to describe the clinical outcomes in patients pancreatic cancer treated with combination of irinotecan, oxaliplatin and cetuximab.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable/metastatic pancreatic cancer treated in the UNM Cancer Research and Treatment Center.
Key inclusion criteria (1 listed)
- Patients with unresectable/metastatic pancreatic cancer treated in the UNM Cancer Research and Treatment Center.
Key exclusion criteria (1 listed)
- Not specified.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Death
Time frame: From date of treatment until time of death
Length of survival of patients treated with a combination of Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Fa-Chyi Lee, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by University of New Mexico at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Feb 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Death (time frame: From date of treatment until time of death). 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 Feb 2024.