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SBRT After Chemotherapy for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Marsha Reyngold, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No evidence of distant metastasis either prior to or after induction chemotherapy
Age ≥18 years
Must not have
Prior abdominal radiotherapy
Male subjects who are unwilling to use effective contraception for the same period as above
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after at least 3 months of induction chemortherapy
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how much SBRT radiation therapy can be given safely to people with pancreatic cancer that can't be removed with surgery.

Who is the study for?
This trial is for adults over 18 with locally advanced, inoperable pancreatic cancer who have completed 3-6 months of standard chemotherapy. They must be able to understand consent and follow breathing instructions for treatment, have no distant metastasis, a tumor size ≤5 cm, good organ function, and an ECOG performance status of 0-1.
What is being tested?
The study aims to determine the highest safe dose of Stereotactic Body Radiotherapy (SBRT) that can be administered after initial chemotherapy in patients with pancreatic cancer that cannot be surgically removed.
What are the potential side effects?
Potential side effects from SBRT may include fatigue, skin reactions at the treatment site, nausea, abdominal pain or discomfort. The severity can vary based on individual patient factors and the specific radiation dose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has not spread to distant parts of my body.
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I am 18 years old or older.
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My cancer is a type of pancreatic cancer confirmed by a lab test.
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My pancreatic cancer cannot be removed by surgery, as confirmed by a CT scan.
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I can follow breathing instructions or tolerate compression to limit movement during treatment.
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I am fully active or can carry out light work.
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My pancreatic tumor is 5 cm or smaller.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiotherapy to my abdomen before.
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I am a male and unwilling to use contraception during the study.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after at least 3 months of induction chemortherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and after at least 3 months of induction chemortherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
maximum tolerated dose (MTD) of SBRT

Side effects data

From 2022 Phase 3 trial • 27 Patients • NCT01926197
100%
Fatigue
100%
Aspartate aminotransferase increased
92%
Diarrhea
92%
Platelet count decreased
83%
Anemia
83%
Weight loss
83%
Alkaline phosphatase increased
83%
Nausea
75%
Pain, abdominal
67%
Decreased appetite (anorexia)
67%
Hypertension
58%
Hyperglycemia
58%
Nerve damage or injury (neuropathy)
58%
Hypokalemia
50%
Alanine aminotransferase increased
50%
White blood cell decreased
50%
Hypoalbuminemia
42%
White blood cell (WBC) count elevated (leukocytosis)
42%
Lymphocyte count decreased
33%
Bloating
33%
Edema, peripheral
25%
Vomiting
25%
Bad taste in mouth (dysgeusia)
25%
Hyponatremia
25%
Anxiety
25%
Pain
25%
Constipation
25%
Hypocalcemia
25%
Labored breathing (dyspnea)
17%
Muscle pain (myalgia)
17%
Indigestion (dyspepsia)
17%
Pain, back
17%
Flatulence
17%
General feeling of discomfort (malaise)
17%
Depression
17%
Hair loss, immune-realted (alopecia)
17%
Neutrophil count decreased
17%
Difficulty sleeping (insomnia)
17%
Oral inflammation (mucositis)
8%
Chills
8%
Fever
8%
Allergic reaction
8%
Bleed (hemorrhage), gastrointestinal
8%
Hearing impaired
8%
Edema, localized
8%
Other, Creatinine decreased
8%
Pain, flank
8%
Muscle weakness lower limb
8%
Drowsiness, unusual (somnolence)
8%
Tiredness (fatigue)
8%
Lymphedema
8%
Thromboembolic event
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Pain, stomach
8%
Pain, chest, non-cardiac
8%
Lymphocyte count increased
8%
Other, Neutrophil count increase
8%
Other, Protein total decrease
8%
Thrombocytopenia
8%
Weight gain
8%
Hypercalcemia
8%
Hypernatremia
8%
Dizziness
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tremor
8%
Rash
8%
Gastroparesis
8%
Flu-like symptoms
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Dehydration
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Confusion
8%
Other, axilla boil
8%
Other, hemoglobin decreased
8%
Infusion-related reaction
8%
Arthritis
8%
Generalized muscle weakness
8%
Memory impairment
8%
Movements involuntary
8%
Chronic kidney disease
8%
Cataract
8%
Other, excess in the stool (steatorrhea)
8%
Other, stool discolored, clay color
8%
Gamma-glutamyl transferase (GGT) increased
8%
Hypoglycemia
8%
Urinary incontinence
8%
Urinary urgency
8%
Urine discoloration
8%
Excessive sweating (hyperhidrosis)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified FOLFIRINOX
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic Body Radiotherapy (SBRT)Experimental Treatment1 Intervention
Cohorts 1-3 After completion of induction chemotherapy, stereotactic body radiotherapy (SBRT) will be administered in 3 fractions, every other day, on an outpatient basis. Dose escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1 Gy per fraction at each dose level, dose level 2 will be 10 Gy x 3 fractions and dose level 3 will be 11 Gy x 3 fractions. Cohorts 4-6 For cohort 4, dose prescription will start at 7 Gy x 6 fractions (42Gy, isoeffective to 11 Gy x 3), followed by 4.8 Gy x 12 (54Gy) and 4.5Gy x 15 (67.5Gy).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy (SBRT)
2017
Completed Phase 3
~550

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,970 Previous Clinical Trials
597,375 Total Patients Enrolled
Marsha Reyngold, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

Stereotactic Body Radiotherapy (SBRT) Clinical Trial Eligibility Overview. Trial Name: NCT02643498 — Phase 1
Pancreatic Cancer Research Study Groups: Stereotactic Body Radiotherapy (SBRT)
Pancreatic Cancer Clinical Trial 2023: Stereotactic Body Radiotherapy (SBRT) Highlights & Side Effects. Trial Name: NCT02643498 — Phase 1
Stereotactic Body Radiotherapy (SBRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02643498 — Phase 1
~1 spots leftby Dec 2025
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