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Anti-metabolites

Image Guided Radiation Therapy for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Gina Vaccaro
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have histologically or cytologically confirmed adenocarcinoma of the pancreas
Tumors must be localized (non-metastatic) and classified as borderline resectable according to Americas Hepato-Pancreato-Biliary Association (AHPBA)/Society of Surgical Oncology (SSO)/Society for Surgery of the Alimentary Tract (SSAT) consensus criteria or be clinically node-positive via computed tomography (CT) or endoscopic ultrasound
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of study drug(s) until 28 days after last study intervention, up to approximately 3 years, 10 months
Awards & highlights

Study Summary

This trial is testing whether a combination of nab-paclitaxel, gemcitabine hydrochloride, and radiation therapy before surgery is more effective than just gemcitabine hydrochloride and radiation therapy before surgery in treating pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of study drug(s) until 28 days after last study intervention, up to approximately 3 years, 10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study drug(s) until 28 days after last study intervention, up to approximately 3 years, 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment
Secondary outcome measures
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0
Overall Survival Rate Defined as the Percentage of Subjects Alive at the 2 Year Time Point
Overall Survival Rate Defined as the Percentage of Subjects Alive at the One Year Time Point
+2 more

Side effects data

From 2022 Phase 2 trial • 20 Patients • NCT02427841
47%
Alopecia
42%
Nausea
42%
Peripheral sensory neuropathy
42%
Fatigue
37%
Maculopapular rash
37%
Neutropenia
32%
Vomiting
21%
Edema Limbs
21%
Thrombocytopenia
21%
Constipation
21%
Fever
21%
Flu-like symptoms
21%
Epistaxis
16%
Dysgeusia
16%
Dyspnea
16%
Diarrhea
16%
Chills
16%
Hypokalemia
11%
Neutropenic fever
11%
Abdominal/flank pain
11%
Elevated liver function tests
11%
Acneiform rash
11%
Hypertension
11%
Anemia
11%
Leukopenia
11%
Non-cardiac chest pain
11%
Anorexia
11%
Febrile neutropenia
5%
Dyspepsia
5%
Superficial thrombophlebitis
5%
Insomnia
5%
Lung infection
5%
Dry mouth
5%
Sinus tachycardia
5%
Thrush
5%
Hypoalbuminemia
5%
Elevated pancreatic enzyme
5%
Skin infection
5%
Headache
5%
Vascular access complication
5%
Gastroesophageal reflux
5%
Localize edema
5%
DIzziness
5%
Transient ischemic attack
5%
Portal vein thrombosis
5%
Fascial Dehiscene
5%
Weight loss
5%
Urticaria
5%
Dry skin
5%
Sore throat
5%
Oral mucositis
5%
Lethargy
5%
Hot flashes
5%
Dehydration
5%
Depression
5%
Palmar-plantar erythrodyesthesia
5%
Generalized muscle weakness
5%
Confusion
5%
Encephalopathy
5%
Abdominal pain
5%
Abdominal wall soft tissue infection
5%
GDA Bleed/Cardiac arrest
5%
Sepsis
5%
Intractable Nausea, vomiting, abdominal pain
5%
Flank pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, chemoradiation therapy, surgery)Experimental Treatment7 Interventions
PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Image Guided Radiation Therapy
2016
Completed Phase 2
~20
Paclitaxel
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860
Gemcitabine
FDA approved
Fluorouracil
FDA approved

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
966 Previous Clinical Trials
6,845,731 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
225 Previous Clinical Trials
2,090,451 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,415 Total Patients Enrolled

Frequently Asked Questions

~2 spots leftby Mar 2025