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Radiation Therapy
SBRT vs Conventional Radiation + Chemotherapy for Pancreatic Cancer
N/A
Recruiting
Led By William Hall, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18.
Ability to swallow oral medications.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks postradiation
Awards & highlights
Study Summary
This trial is testing whether SBRT is better than conventional radiation therapy when given with chemotherapy for patients with inoperable lung cancer.
Who is the study for?
Adults over 18 with a specific type of pancreatic cancer (type A adenocarcinoma) that is resectable, borderline resectable, or locally advanced. They should have had two months of chemotherapy without disease spread and be able to swallow pills. Pregnant women and those not using contraception are excluded.Check my eligibility
What is being tested?
The trial compares two treatments for pancreatic cancer: Arm A receives Stereotactic Body Radiation Therapy (SBRT), while Arm B gets conventional chemotherapy alongside radiation therapy. Patients are randomly assigned to one of these groups.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation like skin irritation, fatigue, nausea, and potential changes in blood counts. Chemotherapy can cause hair loss, mouth sores, increased risk of infection due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can swallow pills.
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My pancreatic cancer is confirmed and considered operable or nearly operable.
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I am not undergoing hemodialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks postradiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks postradiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of subjects who present with node-positive disease following surgical resection.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stereotactic Body Radiation TherapyExperimental Treatment1 Intervention
Patients undergo Stereotactic Body Radiation Therapy (25 to 35 Gy over five fractions)
Group II: Preoperative Fractionated Radiation Therapy and ChemotherapyExperimental Treatment1 Intervention
Concurrent chemotherapy with radiation treatment (50.4 Gy over 28 fractions).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,481 Total Patients Enrolled
William Hall, MDPrincipal Investigator - Medical College of Wisconsin
Froedtert & The Medical College of Wisconsin
3 Previous Clinical Trials
397 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I don't have any major health issues that would prevent me from having major pancreatic surgery.I do not have any ongoing issues with bowel or bile duct blockages.My cancer has spread to distant parts of my body.I have not had major surgery in the last 28 days.I had a severe heart attack in the last 3 months.I am currently on IV antibiotics for a bacterial or fungal infection.I do not have AIDS as defined by the CDC.I can swallow pills.I can take care of myself and am up and about more than half of my waking hours.My pancreatic cancer is confirmed and considered operable or nearly operable.I am not undergoing hemodialysis.I've had chemotherapy for 2 months without my cancer spreading far.My cancer has not spread far or its spread is unclear, as confirmed by a team of doctors.I've had radiation in the same area where my current cancer is.I haven't been hospitalized for lung problems in the last 30 days.I have a condition that severely affects how my body absorbs nutrients.I am not pregnant and willing to use contraception during and after the study.I am not on any non-approved drugs for other conditions.I am using effective birth control methods.I have had a major surgery on my stomach or small intestine that might affect drug absorption.I may or may not have swollen lymph nodes.My hemoglobin level is at least 8.0 g/dl.I've had a recent check-up with weight and vital signs recorded.I've had a recent CT or MRI scan of my abdomen/pelvis with specific techniques.I have not been hospitalized for heart issues in the last 6 months.I can have an MRI and possibly a PET scan for my cancer treatment planning.I have been cancer-free for at least 3 years, except for non-dangerous skin cancers.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Body Radiation Therapy
- Group 2: Preoperative Fractionated Radiation Therapy and Chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the cohort participating in this medical trial?
"Affirmative. Clinicaltrials.gov displays that this clinical trial is currently recruiting participants, first posted on October 22nd 2018 and last edited July 19th 2022. This medical investigation requires 102 individuals from a single site for enrollment."
Answered by AI
Are volunteers currently being sought for this trial?
"Correct. Clinicaltrials.gov reveals that this experiment, which was initially published on October 22nd 2018, is actively recruiting patients. The trial requires 102 participants from 1 location to complete the study."
Answered by AI
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