Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baylor Research Institute
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
\<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
Clareo Health | Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer
