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Phase I Study of Stereotactic Body Radiation Therapy and 5-Fluorouracil, Oxaliplatin and Irinotecan (FOLFIRINOX) in the Neoadjuvant Therapy of Pancreatic Cancer

Phase 1
18 Years
Open (Enrolling)
Cancer of Pancreas, Cancer of the Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreas Neoplasms

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Trial Information

Phase I Study of Stereotactic Body Radiation Therapy and 5-Fluorouracil, Oxaliplatin and Irinotecan (FOLFIRINOX) in the Neoadjuvant Therapy of Pancreatic Cancer

The current standard of care for treating early stage pancreatic cancer involves surgery
followed by chemotherapy and chemoradiotherapy using conventional fractionated external beam
radiation therapy (EBRT). Despite the use of this standard treatment, the outcome for
patients whose pancreatic cancers have been surgically removed remains poor. Patients with
more advanced pancreatic cancers may experience even more inferior outcomes due to the
difficulty to resect the cancer completely. In this particular group of patients,
chemotherapy and radiation are offered to improve the resectability of the cancer.

Traditional chemotherapy used in the treatment of pancreatic cancer has included drugs such
as gemcitabine. Recently, a chemotherapy regimen called Folfirinox has been used in the
treatment of advanced pancreatic cancer. Fofirinox is also associated with improved
outcomes when compared to gemcitabine in this particular group of patients.

Stereotactic body radiotherapy (SBRT) uses a higher dose of radiation to the cancer, but the
treatment lasts for a significantly shorter period of time compared to conventional
radiation. SBRT has advantages over conventional radiation that include: shorter duration of
therapy (one to three days versus two to five weeks) and the ability to deliver full doses
of chemotherapy. Studies evaluating SBRT for patients with pancreatic cancer have shown
that SBRT is as effective as conventional radiation with less toxicity. SBRT combined with
chemotherapy has been very well tolerated in patients with pancreatic cancer.

This study will ask whether giving chemotherapy with Folfirinox followed in short sequence
by radiation therapy using a modified type of radiation, called Stereotactic Body Radiation
Therapy (SBRT), is a feasible and safe approach. Also the investigators would like to see
if this approach can improve the outcomes of patients who may undergo surgery for their
pancreatic cancer.

Inclusion Criteria:

- Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma
with radiological resectable or borderline resectable disease as determined by an
experienced surgical oncologist at Emory.

- Patients must be 21 years or older.

- Patients must not have received prior chemotherapy or radiation for pancreatic

- Patients must have performance status of 0-1 on the ECOG (Eastern Oncology Group)
scale (Appendix II).

- Patients must have adequate bone marrow function: absolute neutrophil count
>1,500/cmm, platelet count >100,000/cmm.

- Patients must be informed of the investigational nature of this study and must give
written informed consent prior to the receiving of treatment per this protocol.

Exclusion Criteria

- Patients with endocrine tumors or lymphoma of the pancreas.

- Patients whose tumor is less than 3 mm from the duodenum as measured by either CT or

- History of central nervous system (CNS) metastases.

- Liver dysfunction, bilirubin > 1.5 mg/dL; aspartate transaminase (AST) and alanine
amino transferase (ALT) > 5 times upper limit of institutional normal.

- Creatinine ≥ 1.5 mg/dL

- Albumin < 2.5 g/dL.

- INR ≥ 1.5 (in the absence of ongoing treatment with warfarin).

- Breast feeding.

- Serious active infection.

- Serious concomitant systemic disorders incompatible with the study (at the discretion
of the investigator).

- Active second primary malignancy (except in situ carcinoma of the cervix, or
adequately treated basal cell carcinoma of the skin) within less than one year of
enrollment into this study.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated total dose of stereotactic body radiation to patients with resectable or borderline resectable pancreas cancer following Folfirinox chemotherapy

Outcome Description:

A standard 3 + 3 design will be used for evaluating the safety and tolerability of SBRT radiation doses. Any grade 3 liver, gastric, small bowel or spinal cord toxicity or any grade 4 toxicity (hematologic or other non-hematologic except for diarrhea) will be considered a dose limiting toxicity (DLT). Each cohort will consist of 3 patients, unless 1 of the patients experiences a DLT in which case the cohort will be expanded to 6 patients. The maximum tolerated dose (MTD) will be defined as the dose level below that which results in a DLT in 2 or more of the 6 patients in a cohort.

Outcome Time Frame:

Four weeks

Safety Issue:


Principal Investigator

Natalyn Hawk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

November 2014

Related Keywords:

  • Cancer of Pancreas
  • Cancer of the Pancreas
  • Neoplasms, Pancreatic
  • Pancreas Cancer
  • Pancreas Neoplasms
  • Cancer of Pancreas
  • Cancer of the Pancreas
  • Neoplasms, Pancreatic
  • Pancreas Cancer
  • Pancreas Neoplasms
  • Entry Term Pancreatic Cancer
  • Neoplasms
  • Pancreatic Neoplasms



Natalyn Hawk, MDAtlanta, Georgia  30322