Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer

Summary

Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates.

This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.

Conditions

• Pancreatic Adenocarcinoma
• Recurrent Pancreatic Carcinoma
• Stage I Pancreatic Cancer AJCC v6 and v7
• Stage IA Pancreatic Cancer AJCC v6 and v7
• Stage IB Pancreatic Cancer AJCC v6 and v7
• Stage II Pancreatic Cancer AJCC v6 and v7
• Stage IIA Pancreatic Cancer AJCC v6 and v7
• Stage IIB Pancreatic Cancer AJCC v6 and v7
• Stage III Pancreatic Cancer AJCC v6 and v7
• Stage IV Pancreatic Cancer AJCC v6 and v7

Interventions

DRUG

Capecitabine

Given by mouth (PO)

DRUG

Fluorouracil

Given Intravenously (IV)

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

RADIATION

Stereotactic Body Radiation Therapy

Undergo hypofractionated stereotactic radiotherapy

DRUG

Zoledronic Acid

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Nebraska

  lead OTHER

Principal Investigators

• Chi Lin, MD, PhD · University of Nebraska

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-16

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations