46 Participants Needed

Stereotactic Body Radiation + Chemotherapy for Pancreatic Cancer

CL
Overseen ByChi Lin, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Chi Lin, MD, PhD
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently taking Zometa, you must stop at least 3 weeks before starting the trial treatment.

Is the combination of Stereotactic Body Radiation and Chemotherapy safe for humans?

Capecitabine (Xeloda) and 5-fluorouracil (5-FU) have been used in various cancer treatments, including colorectal and breast cancer, with generally manageable side effects. Studies have shown that these drugs, when used with radiation therapy, are well tolerated, although the specific safety of the combination with Stereotactic Body Radiation Therapy for pancreatic cancer is not detailed in the available research.12345

How is the treatment of Stereotactic Body Radiation + Chemotherapy for Pancreatic Cancer different from other treatments?

This treatment combines stereotactic body radiation therapy (SBRT), which delivers high doses of radiation precisely to the tumor, with chemotherapy drugs like Capecitabine and Fluorouracil. This approach aims to improve local control and survival rates by targeting the tumor more effectively while sparing surrounding healthy tissue, which is different from traditional chemotherapy or radiation methods that may affect more of the surrounding area.678910

What data supports the effectiveness of the treatment Stereotactic Body Radiation + Chemotherapy for Pancreatic Cancer?

Research indicates that combining fluorouracil (5-FU) with radiation therapy can improve outcomes in gastrointestinal cancers, including pancreatic cancer. Capecitabine, an oral form of 5-FU, has shown promise in enhancing the effects of radiation therapy, potentially leading to better tumor control and increased survival.1112131415

Who Is on the Research Team?

CL

Chi Lin, MD, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for adults with locally advanced pancreatic cancer that hasn't spread far. They should have assessable disease, no recent chemo for other cancers, and their major organs must function well. It's not for those with allergies to Zometa, serious heart issues, pregnant or nursing women, certain prior cancers unless cured over 5 years ago, active severe gastrointestinal problems, HIV infection or liver insufficiency.

Inclusion Criteria

Your platelet count is 100,000/uL or more.
You need to have a certain level of white blood cells called neutrophils in your body.
I had radiation for cancer other than pancreatic over 5 years ago, with no overlap or current cancer.
See 9 more

Exclusion Criteria

I am not allergic to Zometa or anti-nausea medications used in this treatment.
I have no active stomach ulcers, bleeding, serious bowel issues, or history of bowel surgery.
I have HIV or liver problems.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Patients receive zoledronic acid IV over no less than 15 minutes 1 week prior to radiation therapy

1 week

Radiation and Chemotherapy

Patients undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5 and receive fluorouracil IV or capecitabine PO for 4 weeks

4 weeks

Surgery

Patients undergo surgery 6-8 weeks after completion of radiation therapy

6-8 weeks post-radiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days, then every 3 months for the first year, every 4 months for the second year, and every 6 months thereafter

What Are the Treatments Tested in This Trial?

Interventions

  • Capecitabine
  • Fluorouracil
  • Stereotactic Body Radiation Therapy
  • Zoledronic Acid
Trial Overview The study tests if high-dose radiation given in a short time (stereotactic body radiation) combined with chemotherapy drugs fluorouracil or capecitabine improves outcomes. Some patients will also receive zoledronic acid to see if it enhances treatment by making cancer cells more sensitive to radiation.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (zoledronic acid, chemotherapy, radiation therapy)Experimental Treatment6 Interventions
Participants receive zoledronic acid IV over a minimum of 15 minutes 1 week prior to radiation therapy. Participants undergo hypofractionated stereotactic body radiation therapy and receive treatment with fluorouracil IV or capecitabine by mouth as in Arm A. Participants then undergo surgery 6-8 weeks after completion of radiation therapy.
Group II: Arm A (chemotherapy, radiation therapy)Active Control5 Interventions
Participants undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5. Participants receive fluorouracil IV over 24 hours on day 1 weekly for 4 weeks or capecitabine by mouth every 12 hours starting the evening before day 1 of radiation therapy for 4 weeks as per standard of care. Participants then undergo surgery 6-8 weeks after completion of radiation therapy.

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Xeloda for:
  • Colorectal cancer
  • Breast cancer
🇺🇸
Approved in United States as Xeloda for:
  • Colorectal cancer
  • Breast cancer
🇨🇦
Approved in Canada as Xeloda for:
  • Colorectal cancer
  • Breast cancer
🇯🇵
Approved in Japan as Xeloda for:
  • Colorectal cancer
  • Breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Chi Lin, MD, PhD

Lead Sponsor

Trials
3
Recruited
190+

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Combining capecitabine (an oral fluoropyrimidine) with radiation therapy shows promise as a more convenient and effective approach for treating gastrointestinal cancers, with ongoing studies examining its efficacy compared to infusional fluorouracil (5-FU).
Capecitabine's activation to 5-FU is enhanced by thymidine phosphorylase, which is more active in tumor tissues, potentially leading to better drug accumulation in tumors and improved outcomes in radiation therapy, as indicated by ongoing and planned clinical trials.
Capecitabine and radiation therapy for advanced gastrointestinal malignancies.Rich, T.[2015]
In a study of 98 patients with locally advanced pancreatic cancer, capecitabine combined with radiotherapy resulted in significantly lower rates of severe toxicities compared to bolus 5-FU, indicating a safer treatment option.
Both treatment regimens showed similar effectiveness in terms of tumor response rates and overall survival, suggesting that capecitabine is a feasible alternative to 5-FU in chemoradiotherapy for this patient population.
Comparison of capecitabine and 5-fluorouracil in chemoradiotherapy for locally advanced pancreatic cancer.Kim, YJ., Lee, WJ., Woo, SM., et al.[2021]
Recent studies indicate that gemcitabine, either alone or in combination with 5-fluorouracil and radiation, plays a significant role in the treatment of resected and locally advanced pancreatic cancer, although survival rates remain low.
Combination therapies involving gemcitabine with other agents like oxaliplatin or capecitabine have shown improved response rates in clinical trials, but they have not significantly enhanced overall survival according to phase III trial results.
Pancreatic cancer: are we moving forward yet? Highlights from the Gastrointestinal Cancers Symposium. Orlando, FL, USA. January 20th, 2007.Saif, MW.[2018]

Citations

Capecitabine and radiation therapy for advanced gastrointestinal malignancies. [2015]
Comparison of capecitabine and 5-fluorouracil in chemoradiotherapy for locally advanced pancreatic cancer. [2021]
Pancreatic cancer: are we moving forward yet? Highlights from the Gastrointestinal Cancers Symposium. Orlando, FL, USA. January 20th, 2007. [2018]
Protracted 5-fluorouracil infusion with concurrent radiotherapy as a treatment for locally advanced pancreatic carcinoma. [2013]
Chemoradiotherapy as preoperative treatment in locally advanced unresectable pancreatic cancer patients: results of a feasibility study. [2019]
Prospective phase I study of capecitabine and oxaliplatin concurrent with radiation therapy for the treatment of locally advanced pancreatic adenocarcinoma, and retrospective comparison to concurrent 5-fluorouracil/radiation and gemcitabine/radiation. [2022]
Fluoropyrimidines: a critical evaluation. [2017]
Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. [2022]
Potential of Xeloda in colorectal cancer and other solid tumors. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Preoperative chemoradiation using oral capecitabine in locally advanced rectal cancer. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. [2023]
Preoperative treatment with mFOLFIRINOX or Gemcitabine/Nab-paclitaxel +/- isotoxic high-dose stereotactic body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma (the STEREOPAC trial): study protocol for a randomised comparative multicenter phase II trial. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Results of a prospective phase 2 clinical trial of induction gemcitabine/capecitabine followed by stereotactic ablative radiation therapy in borderline resectable or locally advanced pancreatic adenocarcinoma. [2023]
Stereotactic body radiotherapy in pancreatic adenocarcinoma. [2023]
Stereotactic body radiation therapy in pancreatic cancer: the new frontier. [2014]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security