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Anti-metabolites

Stereotactic Body Radiation + Chemotherapy for Pancreatic Cancer

Phase 2

Recruiting

Led By Chi Lin

Research Sponsored by Chi Lin, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All malignant disease must be able to be encompassed within a single irradiation field

Pathologically confirmed adenocarcinoma of the pancreas; patients with either initially diagnosed or recurrent locally advanced disease; the maximum dimension of the treatment target must be =<10 cm; locally advanced disease defined as: T 1-2N+MO or T3-4 NxMo, or borderline resectable and unresectable adenocarcinoma without distant metastatic disease or resectable T3-4 NxMo disease or M1 with controlled distant disease

Must not have

Patients with a known allergy to Zometa or to antiemetics appropriate for administration in conjunction with protocol-directed therapy

Patients with active duodenal ulcer or bleeding or history of a gastrointestinal fistula or perforation or other significant bowel problems (severe nausea, vomiting, inflammatory bowel disease and significant bowel resection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new radiation therapy for pancreatic cancer, to see if it is more effective than current treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include skin irritation from radiation, fatigue from both treatments and potential digestive issues like nausea from chemotherapy. Zoledronic acid can cause flu-like symptoms and may affect kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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All my cancer can be targeted in one radiation treatment area.

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My pancreatic cancer is confirmed and has not spread far or is under control if it has.

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I can care for myself but cannot do normal activities or work.

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My kidneys work well enough (creatinine clearance >= 35).

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My cancer is early stage and hasn't spread but can't be removed with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to Zometa or anti-nausea medications used in this treatment.

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I have no active stomach ulcers, bleeding, serious bowel issues, or history of bowel surgery.

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I have HIV or liver problems.

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I do not have any serious illnesses that could make treatment unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Local control

Secondary study objectives

Local failure-free survival will be compared between patients with and without Zometa

Maximum tolerated dose of zoledronic acid determined by dose limiting toxicities evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Overall survival will be compared between patients with and without Zometa

+5 more

Other study objectives

Pharmacokinetics parameters of zoledronic acid

RNA seq will be used to assess gene expression involved in cholesterol biosynthesis in patients who had resection with or without Zometa

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (zoledronic acid, chemotherapy, radiation therapy)Experimental Treatment6 Interventions

Patients receive zoledronic acid IV over no less than 15 minutes 1 week prior to radiation therapy. Patients undergo hypofractionated stereotactic body radiation therapy and receive treatment with fluorouracil IV or capecitabine PO as in Arm A. Patients then undergo surgery 6-8 weeks after completion of radiation therapy.

Group II: Arm A (chemotherapy, radiation therapy)Active Control5 Interventions

Patients undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5. Patients receive fluorouracil IV over 24 hours on day 1 weekly for 4 weeks or capecitabine PO every 12 hours starting the evening before day 1 of radiation therapy for 4 weeks as per standard of care. Patients then undergo surgery 6-8 weeks after completion of radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~4280

Fluorouracil

2014

Completed Phase 3

~11700