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Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Capecitabine With Concurrent Limited Field Radiation Therapy in Patients With Localized Pancreatic Head Adenocarcinoma

Phase 2
18 Years
80 Years
Open (Enrolling)
Adenocarcinoma of Head of Pancreas

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Trial Information

Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Capecitabine With Concurrent Limited Field Radiation Therapy in Patients With Localized Pancreatic Head Adenocarcinoma

Inclusion Criteria:

- Patient has histologically or cytologically confirmed borderline resectable
adenocarcinoma of the pancreas. Patients with islet cell or other neuroendocrine
neoplasms are excluded.

- Borderline resectable disease2,22 as defined by:

- Staging by intravenous contrast-enhanced thin section helical abdominal computed
tomography (2.5 mm cuts or less) or MRI (for patients with an IV contrast allergy)
using pancreatic protocol. Endoscopic ultrasound is required for tissue acquisition
and staging confirmation:

- AJCC stage III.

- May have abutment of the superior mesenteric artery, (SMA),

- abutment of the celiac axis;

- May have abutment or short segment encasement of the common hepatic artery (CHA);

- May have short segment occlusion of the SMA-PV confluence if reconstruction is

- No evidence of distant disease.

- ≥ 18 years of age.

- Male or non-pregnant and non-lactating female. If a female patient is of childbearing
potential, she must have a negative serum pregnancy test (β hCG) documented within 72
hours of the first administration of study drug.

- If sexually active, the patient must agree to use contraception considered adequate
and appropriate by the Investigator.

- Patient must not have received prior chemotherapy or radiation for pancreatic cancer
and no exposure to systemic chemotherapy.

- Patient has the following blood counts at baseline:

- ANC ≥ 1.5 x 109/L (1500 /mm³)

- Platelets ≥ 125 x 109/L (125,000/mm³)

- Hgb ≥ 10 g/dL.

- Patient has the following blood chemistry levels at baseline:

- AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN)

- Alkaline phosphatase (AP) ≤ 2.5 X ULN

- Total bilirubin ≤ 2.0mg/dl

- Serum creatinine ≤1.5mg/dl or calculated clearance ≥ 50 mL/min/1.73 m² for patients
with serum creatinine levels >1.5 mg/dl.

- Albumin > 2.5 g/dL.

- For patients not receiving anticoagulation: International Normalized Ratio of a
measure of prothrombin time (INR) < 1.3.

- Patient has an ECOG performance status PS 0-1.

- Patient has been informed about the nature of the study and has agreed to participate
in the study and signed the Informed Consent Form prior to participation in any
study-related activities.

- Endoscopic ultrasound (EUS) with FNA for cytology.

- Patients should not have any evidence of active or uncontrolled infection requiring
treatment with antibiotics.

Exclusion Criteria:

- Patient has localized resectable, locally advanced unresectable or advanced
metastatic disease. Patients with adenocarcinoma of the pancreatic body or tail are

- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
systemic therapy.

- Patient has known infection with HIV.

- Patient has undergone major surgery, other than diagnostic surgery ( done
to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior
to Day 1 of treatment in this study.

- Prior chemotherapy, immunotherapy or radiation for pancreatic cancer.

- Patient has a history of allergy or hypersensitivity to the study drugs.

- Patient has serious medical risk factors involving any of the major organ systems
such that the Investigator considers it unsafe for the patient to receive
chemotherapy and/or radiation therapy.

- Patients must not require chronic use of immunosuppressive agents (e.g. methotrexate,

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for five years.

- Patients must not have clinically significant cardiovascular disease (including
myocardial infarction, unstable angina, symptomatic congestive heart failure, serious
uncontrolled cardiac arrhythmia) < 1 year before randomization.

- Patients must not have a history of any medical or psychiatric condition or
laboratory abnormality that in the opinion of the investigator may increase the risks
associated with the study participation or investigational product(s) administration
or may interfere with the interpretation of the results.

- Patient is unwilling or unable to comply with study procedures.

- Patient is enrolled in any other therapeutic clinical protocol or investigational

- Patients aged ≥ 80 are not excluded. However, candidates in this age group should be
thoroughly evaluated before enrollment in the study, to ensure they are fit to
receive chemotherapy, and to potentially undergo pancreaticoduodenectomy. In addition
to meeting all of the baseline patient selection criteria, clinical judgment
regarding the patient's susceptibility to infection, expected stability of their
performance status, and suitability to receive intensive chemotherapy cycles should
be paid special attention. Patients should not be enrolled in the study should there
be any hesitation on any of these considerations. Baseline criteria for all patients
enrolled on the study must be carefully evaluated and all criteria followed

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Objective

Outcome Description:

We will estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. Any patient for whom a surgical sample is not available will be considered a failure (that is, such patients will be counted in the denominator of the estimated proportion, but will contribute a 0 to its numerator). We will also construct exact binomial 95% CIs to provide a measure of the estimated R0/R1 resection rate's precision.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Melanie Thomas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina


United States: Institutional Review Board

Study ID:




Start Date:

July 2012

Completion Date:

September 2014

Related Keywords:

  • Adenocarcinoma of Head of Pancreas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Medical University of South Carolina Charleston, South Carolina  29425-0721