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Phase II Study of First-line Stereotactic Body Radiation Therapy (SBRT) in Patients With Non-Metastatic Unresectable Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Tumor

Thank you

Trial Information

Phase II Study of First-line Stereotactic Body Radiation Therapy (SBRT) in Patients With Non-Metastatic Unresectable Pancreatic Cancer

The standard treatment for cancer of the pancreas is surgery (if possible), external beam
radiation therapy and/or chemotherapy. These standard treatments are not a cure and often
extend life by just a few months. Recently, a new approach has been developed, called
stereotactic body radiation therapy (SBRT). Based on the results of earlier studies using
SBRT, the study doctors at Moffitt feel this is a reasonable alternative to the standard
treatment for your disease.

Stereotactic body radiation therapy (SBRT) delivers high radiation doses to the tumor every
day for 5 days which gives the usual 5-6 week course of radiation in less than a week. It
has also been shown to have much less side effects.

The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer
and to find out what effects, good and/or bad, this treatment will have on you and your

Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research
Imaging). In this subgroup, the investigators want to study if there is early death of tumor
cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by
testing your body's white blood cells taken by a procedure called leukapheresis. You do not
have to take part in the TBRI subgroup to get treatment on this study with SBRT.

Inclusion Criteria

Inclusion Criteria - All Patients:

- Biopsy proven, non-metastatic, pancreatic cancer

- Unresectable disease based on institutional standardized criteria for unresectability

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

- CT scan of chest and abdomen (3-phase pancreas protocol), and PET-CT within 4 weeks
of study entry

- Patients with biliary or gastroduodenal obstruction must have drainage, duodenal
stenting, or gastric bypass prior to initiating radiation

- All disease must be encompassed in a single radiation field

- No evidence or history of an autoimmune dysfunction

- Negative pregnancy test within 7 days of study entry

- No prior or concurrent chemotherapy

- No previous or concurrent immunotherapy for pancreatic cancer

- Liver enzymes ≤ 3 times upper limit of normal (ULN): total bilirubin (Tbili) ≤ 3.9
(biliary stents are allowed); aspartic transaminase (AST) ≤ 177; alanine transaminase
(ALT) ≤ 198; Alkaline phosphatase (ALK-P) ≤ 378

- Adequate pretreatment organ function: Creatinine no greater than 1.5mg/dL; Total
calcium no greater than 11.0mg/dL; prothrombin time (PT) no greater then 14 seconds;
partial thromboplastin time (PTT) no greater then 40 seconds

- Ability to give informed consent

- Adequate baseline hematopoietic function: total white blood cell count equal to or
greater than 3,000/mm³; absolute granulocyte count greater than 1,500/mm³; absolute
lymphocyte count greater than 500/mm³; platelet count equal to or greater than

Inclusion Criteria - TBRI Group:

- All Participant inclusion criteria

- Amenable to leukapheresis as determined by a leukapheresis nurse

- Primary tumor that is accessible to direct intratumoral injection by CT-guidance
confirmed by interventional radiologist

- No history of autoimmune disease

- No history of human immunodeficiency virus (HIV) or acquired immune deficiency
syndrome (AIDS) or other immunosuppressive diseases

- No active viral or bacterial infection

- No use of steroids or any other immunosuppressive drug at least 4 weeks prior to
enrollment on study

Exclusion Criteria - All Patients:

- Prior history of radiotherapy that overlaps with the planned ports to the primary
pancreatic tumor

- Patients with tumors that are not accessible to direct access cannot be included in
the study.

- Prior or concurrent chemotherapy

- Prior history of antineoplastic therapy or irradiation

- Prior treatment with anti-tumor vaccines not allowed

- Patients with a history of autoimmune diseases

- A history of HIV infection, AIDS or other immunosuppressive disease state. The need
to exclude patients with HIV/AIDS is because one of the endpoints of the study is
immune response. People with HIV have a compromised immune system and enrollment in
this study could confound the results (TBRI only)

- Patients requiring corticosteroids are ineligible because one of the endpoints of the
study is immune response. Since steroids modulate the immune system, enrollment of
patients on steroids could confound the results. There must be no use of
corticosteroids in the fours weeks preceding entry into the study (TBRI only).

- Active bacterial, fungal or viral infection

- Active bleeding (hemoptysis, melena, etc.)

- Women who are currently pregnant or actively breast feeding. Women of childbearing
potential must have a negative serum pregnancy test and must use effective
contraception during trial participation

- Any medical or psychiatric illness which in the opinion of the principal investigator
might compromise a patient's ability to tolerate or complete treatment

- Any patient requiring blood thinners (due to risk of gastrointestinal [GI] bleed)

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Overall Survival (OS)

Outcome Description:

Patients will be followed for 36 months to determine overall survival even after completion of the experimental portion of the protocol. Patients will be followed every 3 months. All patients will be referred for chemotherapy at the completion of radiation.

Outcome Time Frame:

36 Months

Safety Issue:


Principal Investigator

Ravi Shridhar, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

August 2015

Related Keywords:

  • Pancreatic Tumor
  • pancreas
  • pancreatic cancer
  • SBRT
  • stereotactic body radiation
  • radiation therapy
  • unresectable
  • non-metastatic
  • tissue, blood, research imaging
  • TBRI
  • Pancreatic Neoplasms