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Radiation Therapy

CyberKnife + Chemotherapy for Pancreatic Cancer

Phase < 1

Waitlist Available

Research Sponsored by The Cooper Health System

Eligibility Criteria Checklist

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

Must have

Medical status suitable for consideration of major pancreatic surgery

Pathologically confirmed adenocarcinoma of the pancreas

Must not have

Prior invasive malignancy within 5 years other than pancreatic adenocarcinoma

Prior radiotherapy to the upper abdomen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

Summary

This trial is testing CyberKnife radiosurgery in combination with chemotherapy to see if it can better treat adenocarcinoma of the pancreas.

Who is the study for?

This trial is for adults over 18 with a specific type of pancreatic cancer that could potentially be removed by surgery. They must have a life expectancy greater than 3 months, no severe other diseases, and agree to use contraception. Those with recent cancers besides pancreatic adenocarcinoma or who've had upper abdomen radiation can't join.

What is being tested?

The study tests combining CyberKnife (a precise form of radiation therapy) with Gemcitabine chemotherapy in patients whose pancreatic cancer might be surgically removed. It aims to see if this combination improves outcomes before surgery.

What are the potential side effects?

CyberKnife treatment may cause fatigue, skin reactions at the treatment site, and nausea. Gemcitabine can lead to side effects like flu-like symptoms, low blood cell counts increasing infection risk, bleeding or bruising easily, and liver function changes.

Eligibility Criteria

Inclusion Criteria

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

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I am medically fit for major pancreatic surgery.

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My diagnosis is pancreatic adenocarcinoma.

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I am older than 18 years.

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My blood vessels near the pancreas are not significantly blocked or can be fixed.

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My condition might be treatable with surgery according to my scans.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My cancer has not spread to organs near the pancreas.

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My cancer has not spread to the area near my celiac trunk and involves less than half of its surrounding area.

Exclusion Criteria

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

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I have not had cancer other than pancreatic cancer in the last 5 years.

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I have had radiation therapy to my upper abdomen.

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My pancreatic cancer has spread beyond the pancreas.

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I cannot have an MRI with contrast for treatment planning.

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I am not taking any other cancer treatment while on this trial.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have a serious health condition that prevents me from having surgery.

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My pancreatic cancer cannot be removed with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

percentage of subjects who successfully undergo pancreaticoduodenectomy

Trial Design

1Treatment groups

Experimental Treatment

Group I: AExperimental Treatment2 Interventions

Chemotherapy: Gemcitabine 1000 mg/m2 weekly x 3 on 28 day cycle Radiation: 25 Gy over 5 fractions Surgery: surgical resection of pancreas treatment plan: 1 cycle of chemotherapy, followed by stereotactic radiosurgery, followed by an additional 6 cycles of chemotherapy or surgical resection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

Gemcitabine

FDA approved

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor

80 Previous Clinical Trials

35,513 Total Patients Enrolled

Media Library

CyberKnife (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02707315 — Phase < 1

Pancreatic Adenocarcinoma Research Study Groups: A

Pancreatic Adenocarcinoma Clinical Trial 2023: CyberKnife Highlights & Side Effects. Trial Name: NCT02707315 — Phase < 1

CyberKnife (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02707315 — Phase < 1

~1 spots leftby Sep 2025

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