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Phase II Study of Preoperative FOLFIRINOX Followed by Accelerated Short Course Radiation Therapy With Proton Beam for Borderline-Resectable Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase II Study of Preoperative FOLFIRINOX Followed by Accelerated Short Course Radiation Therapy With Proton Beam for Borderline-Resectable Pancreatic Cancer

The treatment plan will begin with four cycles (8 weeks) of FOLFIRINOX. Each cycle is 14
days long. You will receive FOLFIRINOX therapy on days 1, 2 and 3 of each of the four
cycles. The FOLFIRINOX treatment is broken up into three different drugs. 5-FU will be
administered over two hours on day one of each cycle, and then continuously with a pump for
days 2 and 3. Oxaliplatin will be delivered by intravenous (infusion)over 120 minutes.
Irinotecan will be given by IV for 90 minutes. All parts of this treatment will be received
as an outpatient.

You will take tablets of capecitabine by mouth for a total of 10 days (Monday through
Friday) during the two weeks after your FOLFIRINOX treatment.

You will be given a drug diary for capecitabine which contains instructions on how to take
the drug.

Proton radiation: You will receive proton radiation treatment for five days (Monday through
Friday) after your FOLFIRINOX treatment, during the time of your capecitabine treatment. You
will also be assessed at least once during this treatment course for any side effects you
may be experiencing.

You will receive study radiation treatment as an outpatient at the Francis H. Burr Proton
Center. This center is located at the Massachusetts General Hospital Surgery is expected to
occur approximately one to four weeks after completion of capecitabine therapy.

After your surgery, you will continue with four additional months of therapy with FOLFIRINOX
if you are well enough to receive it. You will also have follow up visits after surgery
every 3 months for as long as your tumor does not grow.

Inclusion Criteria:

- Cytologic or histologic proof pancreatic ductal carcinoma

- Borderline resectable

- Body and tail lesions

- Life expectancy of at least 3 months

Exclusion Criteria:

- Evidence of metastatic disease

- Pregnant or breastfeeding

- Other serious uncontrolled medical conditions

- Prior chemotherapy, targeted/biologic therapy or radiation for treatment of the
pancreatic tumor

- Prior systemic fluoropyrimidine therapy

- History of uncontrolled seizures, central nervous system disorders or psychiatric

Type of Study:


Study Design:

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

Outcome Measure:

Rate of Resection

Outcome Description:

To determine the rate of R0 resection of patients with borderline-resectable adenocarcinoma of the head of the pancreas, along with borderline-resectable and resectable adenocarcinoma of the body and tail of the pancreas

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Theodore S Hong, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

May 2012

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Borderline resectable
  • Pancreatic Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617