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A Phase II Study of Preoperative Systemic Chemotherapy (Modified FOLFIRINOX) Followed by Radiation Therapy for Patients With High Risk Resectable and Borderline Resectable Adenocarcinoma of the Pancreas

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

Thank you

Trial Information

A Phase II Study of Preoperative Systemic Chemotherapy (Modified FOLFIRINOX) Followed by Radiation Therapy for Patients With High Risk Resectable and Borderline Resectable Adenocarcinoma of the Pancreas

Study Drug Administration:

You will receive up to 3 phases of study therapy: the systemic chemotherapy phase, the
chemoradiation phase, and surgery, if possible.

During the systemic chemotherapy phase, you will receive mFolfirinox 1 time every 2 weeks
(Weeks 1, 3, 5, 7, 9 and 11) for 12 weeks. You will receive oxaliplatin by vein over a
2-hour period. After receiving oxaliplatin, you will receive irinotecan by vein over a
90-minute period. After receiving irinotecan, you will then receive 5-FU through a portable
pump for the next 46 hours. You will take the portable pump home with you and will receive
instructions on how to use it.

You will begin receiving chemoradiation within 6 weeks after you have finished receiving the
Week 11 dose of mFolfirinox. However, you will not begin receiving it until you have
recovered from side effects of the chemotherapy.

During the chemoradiation phase, you will receive gemcitabine over about 35 minutes 1 time
each week for 5 weeks. You will also receive radiation therapy 5 days a week (Monday
through Friday) for 5 1/2 weeks (a total of 28 treatments). If you miss any of the days of
radiation, they will be made up at the end of treatment so that you will receive the full
amount of radiation. You will be given a separate consent form that explains the radiation
procedure and the risks it may present.

After the chemoradiation phase, you will not receive any treatment for 4-6 weeks so your
body can recover. If after this time the disease has not gotten worse or spread to other
parts of the body, you will have surgery to try to remove the tumor. You will be given a
separate consent form for the surgery that describes how it is performed and its risks.

If the disease has gotten worse or spread to other parts of the body, you will not be able
to have surgery. The study doctor will discuss other therapy options with you.

Study Visits:

At Weeks 1, 3, 5, 7, 9, and 11 of the systemic chemotherapy phase:

- You will have a physical exam, including measurement of your weight and vital signs
(blood pressure and heart rate).

- Blood (about 3 tablespoons) will be drawn for routine tests.

Within 4 weeks before beginning the chemoradiation phase:

- You will have CT or MRI scans to check the status of the disease.

- Blood (about 1 tablespoon) will be drawn for tumor marker testing.

At Weeks 1, 2, 3, 4, 5, and 6 of the chemoradiation phase:

- You will have a physical exam, including measurement of your weight and vital signs.

- Blood (about 2-3 tablespoons) will be collected for routine tests. At Week 6, an
additional 2 teaspoons of blood will be drawn for CTC testing.

About 4 to 6 weeks after you complete the chemoradiation phase:

- Blood (about 1 tablespoon) will be drawn for tumor marker testing.

- You will have CT or MRI scans to check the status of the disease.

If you are eligible to have surgery after the chemoradiation phase, the following tests and
procedures will also be performed:

- Blood (about 4 teaspoons total) will be drawn within 2 weeks before surgery for CTC
testing. Blood will also be collected during surgery, if the surgeon thinks it is safe
and feasible.

- Tumor tissue collected during a previous procedure will be used for biomarker testing.
An additional sample of tumor tissue will be collected from the tissue removed during
surgery and used for biomarker testing. Biomarkers are found in the blood/tissue and
may be related to your reaction to the study drug.

Length of Study:

You will receive study treatment over the course of up to 30 weeks. You will be taken off
study if the disease gets worse, the study doctor thinks it is in your best interest, or if
you do not follow the study directions.

You may choose to stop receiving the study treatment at any time. If you choose to stop,
you should tell the study doctor or a member of the staff right away. They will make sure
that proper procedures are followed and a final visit will be scheduled for your safety.


Blood (about 2 teaspoons) will be collected for CTC testing 2-3 months after your surgery,
if you were one of the first 30 participants enrolled in the study.

You will have a CT or MRI scan of the abdomen and pelvis every 4 months for 2 years to check
the status of the disease.

This is an investigational study. 5-FU, oxaliplatin, irinotecan, and gemcitabine are each
FDA approved and commercially available to treat different types of cancer:

- 5-FU: pancreatic, gastric, breast, colon/rectum, and skin cancer (basal cell

- Oxaliplatin: colon and rectal cancer

- Irinotecan: colorectal cancer

- Gemcitabine: pancreatic, lung, ovarian, and breast cancer.

The use of these 4 drugs together and in combination with radiation therapy for the
treatment of pancreatic cancer is investigational.

Up to 66 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to
treatment. Patients with Islet cell tumors are not eligible.

2. Only untreated patients with high risk pancreatic adenocarcinomas will be eligible
for the study. For this study, such patients are defined as those who meet one or
more of the following radiographic or serologic criteria: a)Primary tumor that
involves the superior mesenteric vein causing a vein deformity or segmental venous
occlusion with a patent vessel above and below suitable for reconstruction. b)Primary
tumor that involves axis or any of its branches on CT or MRI. c) Primary tumor that abuts or encases (>/=
50% of the vessel circumference) a short segment of the common hepatic artery
(typically at the gastroduodenal artery origin)

3. (continuation of #2). d) Patients with a high CA19-9 (=/>500mg/dl) in the presence of
a bilirubin =/< 2.0 mg/dL. e) Radiographic findings consistent with malignant
peripancreatic lymphadenopathy outside the planned field on CT or MRI f) Radiographic
findings of indeterminate liver or peritoneal lesions on CT or MRI concerning but not
diagnostic of metastatic disease.

4. Patients cannot have known hepatic or peritoneal metastases detected by ultrasound
(US), CT scan, MRI or laparotomy.

5. There will be no upper age restriction; patients with Eastern Cooperative Oncology
Group (ECOG) 0-1 are eligible.

6. Adequate renal, and bone marrow function: a) Leukocytes >/= 3,000/uL. b) Absolute
neutrophil count >/=1,500/uL.c) Platelets >/=100,000/Ul. d) Serum creatinine mg/dL.

7. Hepatic function (endoscopic or percutaneous drainage as needed). a)Total bilirubin
institutional ULN.

8. Patients must have no fever or evidence of infection or other coexisting medical
condition that would preclude protocol therapy.

9. Women of childbearing potential (defined as those who have not undergone a
hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
must agree to practice adequate contraception and to refrain from breast feeding.

10. Patients must sign a study-specific consent form.

Exclusion Criteria:

1. Patients whose tumors are defined as locally advanced cancer or metastatic cancer are
not eligible.

2. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive
heart failure; multiple comorbidity that preclude a major abdominal surgery.

3. Known presence of metastases.

4. Inability to comply with study and/or follow-up procedures.

5. Patients < 18 years of age.

6. Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this

7. Patients with an active second malignancy with the exception of non-melanoma skin

Type of Study:


Study Design:

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

Outcome Measure:

Resection Rate

Outcome Description:

Resectability rate defined as proportion of participants who undergo surgery among all enrolled participants. The Simon's optimum two-stage design is applied in this study. Sample size of 66 is chosen to differentiate between good resectability rate of 60% and poor resectability rate of 40% with 90% power and at a significance level of 0.05. Resectability rate estimated, along with the 95% confidence interval, using intent-to-treat (ITT) principle.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Gauri Varadhachary, MD, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Adenocarcinoma of the Pancreas
  • High Risk Resectable
  • Borderline Resectable
  • Chemotherapy
  • Chemoradiation therapy
  • Oxaliplatin
  • Eloxatin
  • Irinotecan
  • CPT-11
  • Camptosar
  • 5-FU
  • 5-Fluorouracil
  • Adrucil
  • Efudex
  • Gemcitabine
  • Gemcitabine Hydrochloride
  • Gemzar
  • Radiation Therapy
  • XRT
  • RT
  • External Beam Radiation Therapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030