CClinicalTrials.gg
Status unknownNCT01771146Updated Jan 31, 2017

Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

An interventional study of FOLFIRINOX Regimen in Pancreas Cancer, Localized Pancreas Cancer and Non-metastatic Pancreas Cancer, sponsored by Baylor Research Institute. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-31.

Sponsored by Baylor Research Institute · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Pancreas Cancer
  • Localized Pancreas Cancer
  • Non-metastatic Pancreas Cancer

Keywords

  • Non-metastatic Pancreas Cancer
  • Pancreatic Cancer
  • Cancer of Pancreas
  • Adenocarcinoma of Pancreas
  • Neoadjuvant
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 30 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • \<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
  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Neoadjuvant FOLFIRINOX Regimen

    Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection

    Drug: FOLFIRINOX Regimen

Interventions

  • DrugFOLFIRINOX Regimen

    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

    Also known as: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU, Eloxatin, Camptosar, Adrucil

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. • The length of time from diagnosis (enrollment) to death

    Time frame: Up to 5 years

  2. • 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

  3. • R0 resection as defined as microscopically negative margins

    Time frame: Up to 5 years

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Study locations

1 site
  • Baylor University Medical Center - Texas Oncology
    Dallas, Texas 75246, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01771146
Lead sponsor
Baylor Research Institute
Responsible party
Sponsor
First posted
Jan 18, 2013
Start date
Oct 2012
Primary completion
Sep 2017 (estimated)
Completion
Sep 2020 (estimated)
Last update
Jan 31, 2017

Study contacts

Scott Celinski, MD
principal investigator · Baylor Health Care System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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