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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after at least 3 months of induction chemortherapy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after at least 3 months of induction chemortherapy

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Other, Creatinine decreased

Pain, flank

Lymphedema

Hearing impaired

Bleed (hemorrhage), gastrointestinal

Edema, localized

Thromboembolic event

Allergic reaction

Chills

Fever

Drowsiness, unusual (somnolence)

Tiredness (fatigue)

Muscle weakness lower limb

Abdominal distention

Abnormal sensation in the mouth (oral dysesthesia)

Dry mouth

Gastroesophageal reflux disease

Pain, stomach

Pain, chest, non-cardiac

Lymphocyte count increased

Other, Neutrophil count increase

Other, Protein total decrease

Thrombocytopenia

Weight gain

Hypercalcemia

Hypernatremia

Dizziness

Nerve tingling (paresthesia)

Slow or slurred speech (dysarthria)

Tremor

Rash

Gastroparesis

Flu-like symptoms

Alkaline phosphatase decreased

Blood bilirubin increased

Dehydration

Nerve damage or injury (neuropathy), peripheral sensory

Confusion

Other, axilla boil

Other, hemoglobin decreased

Infusion-related reaction

Arthritis

Generalized muscle weakness

Memory impairment

Movements involuntary

Chronic kidney disease

Cataract

Other, excess in the stool (steatorrhea)

Other, stool discolored, clay color

Gamma-glutamyl transferase (GGT) increased

Hypoglycemia

Urinary incontinence

Urinary urgency

Urine discoloration

Excessive sweating (hyperhidrosis)

100%

80%

60%

40%

20%

Study treatment Arm

Modified FOLFIRINOX

Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

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)

2016

Completed Phase 3

~580

0 / 7Eligibility criteria met