Pancreas CancerNCT01771146
Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer
A study testing FOLFIRINOX Regimen in people with Pancreas Cancer and Localized Pancreas Cancer, run by Baylor Research Institute at 1 site in United States.
Trial summary
A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Localized Pancreas Cancer, Non-metastatic Pancreas Cancer
- What is being tested?
- FOLFIRINOX Regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2020
- Phase
- Interventional
- 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
- 18 years of age or older
- Male or non-pregnant and non-lactating female
- Histologically or cytologically confirmed adenocarcinoma of pancreas
- Patients must have satisfactory blood counts and blood chemistry levels at baseline (refer to Appendix 2, Study Laboratory References Range).
- Patient has Eastern Cooperative Oncology Group(ECOG) Performance Status 0 to 1 (refer to Appendix 7):
- 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
- 1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
- Signed study consent form
Who cannot join
- <18 years of age
- Pregnant or lactating female
- Patient has islet cell neoplasms
- Patient has known brain metastases
- Patient has metastatic disease
- Active secondary malignancies
Show all 17Show fewer
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Known infection with hepatitis B, hepatitis C, or cirrhosis
- Major surgery or vascular device placement (excluding ports for IV medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study
- Prior chemotherapy or radiation for pancreatic cancer
- History of allergy or hypersensitivity to the study drugs
- Patient is enrolled in any outside (outside Baylor University Medical Center or Texas Oncology) clinical protocol or investigational trial
- Significant cardiac disease as defined as New York Heart Association (NYHA) classification III or IV, uncontrolled congestive heart failure (CHF), or prior myocardial infarction (MI) last 6-months
- Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk
- Peripheral sensory neuropathy ≥ to grade 2 at baseline
- Significant co-morbidities deemed by investigator as unsuitable for participation/enrollment
- Study consent form not signed
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center - Texas Oncology
Dallas, Texas, 75246
About this study
Official title: A Prospective Evaluation of Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancreas Cancer (Baylor University Medical Center and Texas Oncology Experience)
A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)
Read the detailed description
Patients with pancreas cancer will be enrolled and treated with a planned course of 6 cycles (3 months) of chemotherapy with FOLFIRINOX prior to undergoing surgical resection.
- Being tested
- FOLFIRINOX Regimen
- Keywords
- Non-metastatic Pancreas Cancer, Pancreatic Cancer, Cancer of Pancreas, Adenocarcinoma of Pancreas, Neoadjuvant
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRINOX RegimenDrug
Also called FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU
6 cycles of FOLFIRINOX prior to surgical resection: Eloxatin® (Oxaliplatin) 85 mg per square meter 2-hour IV infusion Camptosar® (Irinotecan Hydrochloride) 180 mg per square meter 90-minute IV infusion via Y-connector adrucil (Fluorouracil; 5-FU)2400 mg per square meter 46-hour IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant FOLFIRINOX Regimen | Other | Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection Receives: Drug: FOLFIRINOX Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as defined by the length of time that a patient survives without any signs or symptoms of that cancer or any other type of cancer
Measured: Up to 5 years
Secondary outcomes (3)
• The length of time from diagnosis (enrollment) to death
Measured: Up to 5 years
• Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis
Measured: Up to 5 years
• R0 resection as defined as microscopically negative margins
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2017 (estimated)
- Study completionSep 2020 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Celinski, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771146
- Sponsor's protocol ID
- 012-180
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancreas Cancer (Baylor University Medical Center and Texas Oncology Experience)
- ClinicalTrials.gov ID
- NCT01771146
- Acronym / sponsor ID
- 012-180
- Keywords
- Non-metastatic Pancreas Cancer, Pancreatic Cancer, Cancer of Pancreas, Adenocarcinoma of Pancreas, Neoadjuvant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 18 Jan 2013 (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 prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)
Detailed description
Patients with pancreas cancer will be enrolled and treated with a planned course of 6 cycles (3 months) of chemotherapy with FOLFIRINOX prior to undergoing surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant FOLFIRINOX Regimen | Other | Drug: FOLFIRINOX RegimenSingle arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Male or non-pregnant and non-lactating female
- Histologically or cytologically confirmed adenocarcinoma of pancreas
- Patients must have satisfactory blood counts and blood chemistry levels at baseline (refer to Appendix 2, Study Laboratory References Range).
- Patient has Eastern Cooperative Oncology Group(ECOG) Performance Status 0 to 1 (refer to Appendix 7):
Key exclusion criteria (17 listed)
- <18 years of age
- Pregnant or lactating female
- Patient has islet cell neoplasms
- Patient has known brain metastases
- Patient has metastatic disease
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 |
|---|---|---|
| FOLFIRINOX RegimenAlso: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU6 cycles of FOLFIRINOX prior to surgical resection: Eloxatin® (Oxaliplatin) 85 mg per square meter 2-hour IV infusion Camptosar® (Irinotecan Hydrochloride) 180 mg per square meter 90-minute IV infusion via Y-connector adrucil (Fluorouracil; 5-FU)2400 mg per square meter 46-hour IV infusion | Drug | Neoadjuvant FOLFIRINOX Regimen |
Primary outcome
Progression Free Survival (PFS) as defined by the length of time that a patient survives without any signs or symptoms of that cancer or any other type of cancer
Time frame: Up to 5 years
3 secondary outcomes
• The length of time from diagnosis (enrollment) to death
Time frame: Up to 5 years
• Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis
Time frame: Up to 5 years
• R0 resection as defined as microscopically negative margins
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Scott Celinski, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOLFIRINOX Regimen in people with Pancreas Cancer and Localized Pancreas Cancer, run by Baylor Research Institute 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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 31 Jan 2017. 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?
Results are not available in the source record.
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 (PFS) as defined by the length of time that a patient survives without any signs or symptoms of that cancer or any other type of cancer (time frame: 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 31 Jan 2017; AzTrials last refreshed its copy on 27 Oct 2026.