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Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer (LAP100)

Treatment

Radiation treatment study for people with locally advanced pancreatic cancer

Clinicaltrials.gov identifier:
NCT06958328

Study Contact Information:

Contact Nina Sanford at: 
Nina.Sanford@UTSouthwestern.edu

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This research study will test whether higher doses of radiation therapy are safe and effective for people with locally advanced pancreatic cancer. The goal is to see if stronger doses can shrink or control the cancer better than standard doses, without causing too many side effects. People who have been diagnosed with locally advanced pancreatic cancer and have not had surgery to remove the tumor may be eligible.

This Study is Open To:

People may be eligible if they:

  • have been diagnosed with locally advanced pancreatic cancer (cancer that has not spread to distant parts of the body but cannot be removed by surgery). 
  • have received 4-6 months of chemotherapy with one of the following regimens:
    • folfirinox (8-12 cycles).  
    • nalirifox (8-12 cycles).  
    • gemcitabine/nab-paclitaxel (4-6 cycles).

After receiving chemotherapy, patients may be eligible if: 

  • their scans showing at least stable disease (no progression).
  • if their CA19-9 drops or remains stable:
    • for participants whose baseline (before chemotherapy) CA19-9 was elevated (defined as > 37 u/mL) after chemotherapy their CA19-9 must be less than 37 u/mL or show a 50% drop from pre-chemotherapy level with absolute value less than 100u/mL.
    • for participants whose baseline (before chemotherapy) CA19-9 was not elevated (defined as 37 u/mL or less), the post-pre-entry chemotherapy CA19-9 must remain 37 u/mL or less.​​​​​

This Study is NOT Open To:

Participants are not eligible if they:

  • have active duodenal (small intestine) or gastric (stomach) ulcers.
  • have a tumor that has invaded the bowel or stomach.
  • are pregnant or breastfeeding. 
  • have a heart condition resulting in hospitatlization in the last 6 months

People will be selected at random for one of two groups. 

Group 1 (Standard-of-Care Group):

Participants in Group 1:

  • will receive 4-6 months of chemotherapy as directed by their doctor.
  • who require radiation will receive standard dose radiation therapy once daily for 28 days and receive fluorouracil or capecitabine during radiation therapy.
  • will be encouraged to receive at least 6 months of chemotherapy. Participants may continue treatment beyond 6 months based on their doctor's recommendation.
  • will provide blood samples, CT scans, scans and tumor tissue biopsy throughout the study. 

Group 2 (Dose Escalated Radiation Therapy Group): 

Participants in Group 2:

  • will receive 4-6 months of chemotherapy as directed by their doctor.
  • will receive dose-escalated radiation therapy every other day, or twice weekly, for 5 weeks or daily for 25 days. 
  • who received less than 6 months of chemotherapy at the beginning of the study will be encouraged to reeive the remaining chemotherapy to total 6 months of chemotherapy. Participants may continue treatment beyond 6 months if directed by their doctor.
  • will provide blood samples, CT scans, scans and tumor tissue biopsy throughout the study. 

After completion of study treatment, all participants will be followed every 3 months for 2 years then annually for 3 years.

 

Study Contact Information:

Contact Nina Sanford at: 
Nina.Sanford@UTSouthwestern.edu

Locations:

Arkansas

City: Jonesboro RECRUITING
Facility: NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Contact Info:
Emily.Carvell@bmhcc.org 870-936-7066
Shelby Lane

Arizona

City: Gilbert RECRUITING
Facility: Arizona Center for Cancer Care - Gilbert
Contact Info:
penny.labriola@arizonaccc.com 480-278-8261
Steven E. Sckolnik

City: Peoria RECRUITING
Facility: Arizona Center for Cancer Care-Peoria
Contact Info:
623-773-2873
Steven E. Sckolnik

City: Phoenix RECRUITING
Facility: Arizona Center for Cancer Care - Phoenix
Contact Info:
penny.labriola@arizonaccc.com 480-278-8261
Steven E. Sckolnik

City: Scottsdale RECRUITING
Facility: Arizona Center for Cancer Care - Scottsdale
Contact Info:
penny.labriola@arizonaccc.com 480-278-8261
Steven E. Sckolnik

City: Surprise RECRUITING
Facility: Arizona Center for Cancer Care-Surprise
Contact Info:
Roster@nrgoncology.org 412-339-5294
Steven E. Sckolnik

City: Tempe RECRUITING
Facility: Arizona Center for Cancer Care
Contact Info:
penny.labriola@arizonaccc.com 480-278-8261
Steven E. Sckolnik

California

City: Bakersfield RECRUITING
Facility: AIS Cancer Center at San Joaquin Community Hospital
Contact Info:
661-323-4673
Luis Mariscal

City: Berkeley RECRUITING
Facility: Alta Bates Summit Medical Center-Herrick Campus
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Cameron Park RECRUITING
Facility: Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Fremont RECRUITING
Facility: Palo Alto Medical Foundation-Fremont
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Modesto RECRUITING
Facility: Memorial Medical Center
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Mountain View RECRUITING
Facility: Palo Alto Medical Foundation-Camino Division
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Palo Alto RECRUITING
Facility: Palo Alto Medical Foundation Health Care
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Roseville RECRUITING
Facility: Sutter Cancer Centers Radiation Oncology Services-Roseville
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Roseville RECRUITING
Facility: Sutter Roseville Medical Center
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Sacramento RECRUITING
Facility: Sutter Medical Center Sacramento
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Santa Barbara RECRUITING
Facility: Ridley-Tree Cancer Center
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Santa Rosa RECRUITING
Facility: Sutter Pacific Medical Foundation
Contact Info:
clinicalresearch@sutterhealth.org 415-209-2683
Christopher U. Jones

City: Sunnyvale RECRUITING
Facility: Palo Alto Medical Foundation-Sunnyvale
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Vallejo RECRUITING
Facility: Sutter Solano Medical Center/Cancer Center
Contact Info:
clinicalresearch@sutterhealth.org
Christopher U. Jones

City: Walnut Creek RECRUITING
Facility: BASS Medical Group - Lennon
Contact Info:
brenna.lindsey@bassmedicalgroup.com 307-760-7636
Nicholas J. DiBella

Colorado

City: Boulder RECRUITING
Facility: Rocky Mountain Cancer Centers-Boulder
Contact Info:
info@westernstatesncorp.org 303-777-2663
Nicholas J. DiBella

Florida

City: Gainesville RECRUITING
Facility: University of Florida Health Science Center - Gainesville
Contact Info:
cancer-center@ufl.edu 352-273-8010
Kathryn E. Hitchcock

Georgia

City: Savannah RECRUITING
Facility: Memorial Health University Medical Center
Contact Info:
Lorraine.OHara@hcahealthcare.com 912-350-7887
Michael D. Hasselle

Iowa

City: Ankeny RECRUITING
Facility: UI Health Care Mission Cancer and Blood - Ankeny Clinic
Contact Info:
515-241-3305
Seema Harichand-Herdt

City: Clive RECRUITING
Facility: UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Contact Info:
515-241-3305
Seema Harichand-Herdt

City: Des Moines RECRUITING
Facility: Iowa Methodist Medical Center
Contact Info:
515-241-6727
Seema Harichand-Herdt

City: Des Moines RECRUITING
Facility: UI Health Care Mission Cancer and Blood - Des Moines Clinic
Contact Info:
515-241-3305
Seema Harichand-Herdt

City: Des Moines RECRUITING
Facility: UI Health Care Mission Cancer and Blood - Laurel Clinic
Contact Info:
515-241-3305
Seema Harichand-Herdt

City: Waukee RECRUITING
Facility: UI Health Care Mission Cancer and Blood - Waukee Clinic
Contact Info:
515-241-3305
Seema Harichand-Herdt

Illinois

City: Aurora RECRUITING
Facility: Rush-Copley Medical Center
Contact Info:
RCMC_Cancer_Research@rush.edu 630-978-6212
Daniel H. Barnett

City: Centralia RECRUITING
Facility: Centralia Oncology Clinic
Contact Info:
morganthaler.jodi@mhsil.com 217-876-4762
Bryan A. Faller

City: Danville RECRUITING
Facility: Carle at The Riverfront
Contact Info:
Research@Carle.com 800-446-5532
Daniel H. Barnett

City: Decatur RECRUITING
Facility: Cancer Care Specialists of Illinois - Decatur
Contact Info:
morganthaler.jodi@mhsil.com 217-876-4762
Bryan A. Faller

City: Decatur RECRUITING
Facility: Decatur Memorial Hospital
Contact Info:
morganthaler.jodi@mhsil.com 217-876-4762
Bryan A. Faller

City: Effingham RECRUITING
Facility: Carle Physician Group-Effingham
Contact Info:
Research@carle.com 800-446-5532
Daniel H. Barnett

City: Effingham RECRUITING
Facility: Crossroads Cancer Center
Contact Info:
morganthaler.jodi@mhsil.com 217-876-4762
Bryan A. Faller

City: Mattoon RECRUITING
Facility: Carle Physician Group-Mattoon/Charleston
Contact Info:
Research@carle.com 800-446-5532
Daniel H. Barnett

City: O'Fallon RECRUITING
Facility: Cancer Care Center of O'Fallon
Contact Info:
morganthaler.jodi@mhsil.com 217-876-4762
Bryan A. Faller

City: O'Fallon RECRUITING
Facility: HSHS Saint Elizabeth's Hospital
Contact Info:
morganthaler.jodi@mhsil.com 217-876-4762
Bryan A. Faller

City: Springfield RECRUITING
Facility: Southern Illinois University School of Medicine
Contact Info:
217-545-7929
Bryan A. Faller

City: Springfield RECRUITING
Facility: Springfield Clinic
Contact Info:
800-444-7541
Bryan A. Faller

City: Springfield RECRUITING
Facility: Springfield Memorial Hospital
Contact Info:
pallante.beth@mhsil.com 217-528-7541
Bryan A. Faller

City: Urbana RECRUITING
Facility: Carle Cancer Center
Contact Info:
Research@carle.com 800-446-5532
Daniel H. Barnett

Indiana

City: Goshen RECRUITING
Facility: Goshen Center for Cancer Care
Contact Info:
cccois@goshenhealth.com 574-364-2973
James A. Wheeler

Kansas

City: Kansas City RECRUITING
Facility: University of Kansas Cancer Center
Contact Info:
KUCC_Navigation@kumc.edu 913-588-3671
Ryan T. Morse

City: Olathe RECRUITING
Facility: The University of Kansas Cancer Center - Olathe
Contact Info:
OlatheCCResearch@kumc.edu 913-588-1569
Ryan T. Morse

City: Overland Park RECRUITING
Facility: University of Kansas Cancer Center-Overland Park
Contact Info:
KUCC_Navigation@kumc.edu 913-588-3671
Ryan T. Morse

City: Topeka RECRUITING
Facility: University of Kansas Health System Saint Francis Campus
Contact Info:
785-295-8000
Ryan T. Morse

City: Westwood RECRUITING
Facility: University of Kansas Hospital-Westwood Cancer Center
Contact Info:
KUCC_Navigation@kumc.edu 913-588-3671
Ryan T. Morse

Kentucky

City: Lexington RECRUITING
Facility: University of Kentucky/Markey Cancer Center
Contact Info:
859-257-3379
Mark E. Bernard

Maryland

City: Baltimore RECRUITING
Facility: Sinai Hospital of Baltimore
Contact Info:
410-601-9083
David J. Perry

City: Westminster RECRUITING
Facility: William E Kahlert Regional Cancer Center/Sinai Hospital
Contact Info:
410-871-6400
David J. Perry

Michigan

City: Clinton Township RECRUITING
Facility: Henry Ford Macomb Hospital-Clinton Township
Contact Info:
CTOResearch@hfhs.org 313-916-3721
Parag J. Parikh

City: Dearborn RECRUITING
Facility: Henry Ford Medical Center-Fairlane
Contact Info:
CTOResearch@hfhs.org 313-916-3721
Parag J. Parikh

City: Detroit RECRUITING
Facility: Henry Ford Hospital
Contact Info:
CTOResearch@hfhs.org 313-916-3721
Parag J. Parikh

City: Jackson RECRUITING
Facility: Allegiance Health
Contact Info:
CTOResearch@hfhs.org 313-916-3721
Parag J. Parikh

City: Novi RECRUITING
Facility: Henry Ford Medical Center-Columbus
Contact Info:
CTOResearch@hfhs.org 313-916-3721
Parag J. Parikh

City: West Bloomfield RECRUITING
Facility: Henry Ford West Bloomfield Hospital
Contact Info:
CTOResearch@hfhs.org 313-916-3721
Parag J. Parikh

Missouri

City: Kansas City RECRUITING
Facility: University of Kansas Cancer Center - North
Contact Info:
KUCC_Navigation@kumc.edu 913-588-3671
Ryan T. Morse

City: Lee's Summit RECRUITING
Facility: University of Kansas Cancer Center - Lee's Summit
Contact Info:
KUCC_Navigation@kumc.edu 913-588-3671
Ryan T. Morse

Mississippi

City: Columbus RECRUITING
Facility: Baptist Memorial Hospital and Cancer Center-Golden Triangle
Contact Info:
BCCclintrials@bmhcc.org 901-226-1366
Shelby Lane

City: Grenada RECRUITING
Facility: Baptist Cancer Center-Grenada
Contact Info:
BCCclintrials@bmhcc.org 901-226-1366
Shelby Lane

City: New Albany RECRUITING
Facility: Baptist Memorial Hospital and Cancer Center-Union County
Contact Info:
BCCclintrials@bmhcc.org 901-226-1366
Shelby Lane

City: Oxford RECRUITING
Facility: Baptist Memorial Hospital and Cancer Center-Oxford
Contact Info:
BCCclintrials@bmhcc.org 901-226-1366
Shelby Lane

City: Southhaven RECRUITING
Facility: Baptist Memorial Hospital and Cancer Center-Desoto
Contact Info:
BCCclintrials@bmhcc.org 901-226-1366
Shelby Lane

North Carolina

City: Chapel Hill RECRUITING
Facility: UNC Lineberger Comprehensive Cancer Center
Contact Info:
cancerclinicaltrials@med.unc.edu 877-668-0683
Theodore K. Yanagihara

Nebraska

City: Omaha RECRUITING
Facility: University of Nebraska Medical Center
Contact Info:
unmcrsa@unmc.edu 402-559-6941
Chi Lin

New Hampshire

City: Lebanon RECRUITING
Facility: Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Contact Info:
cancer.research.nurse@dartmouth.edu 800-639-6918
Bassem I. Zaki

Nevada

City: Reno RECRUITING
Facility: Renown Regional Medical Center
Contact Info:
research@sncrf.org 702-384-0013
Alan K. Ikeda

Ohio

City: Cincinnati RECRUITING
Facility: University of Cincinnati Cancer Center-UC Medical Center
Contact Info:
cancer@uchealth.com 513-584-7698
Jordan Kharofa

City: Sylvania RECRUITING
Facility: ProMedica Flower Hospital
Contact Info:
PCIOncResearch@promedica.org 419-824-1842
Eric P. Kielhorn

City: Toledo RECRUITING
Facility: ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Contact Info:
PCIOncResearch@promedica.org 419-824-1842
Eric P. Kielhorn

City: West Chester RECRUITING
Facility: University of Cincinnati Cancer Center-West Chester
Contact Info:
cancer@uchealth.com 513-584-7698
Jordan Kharofa

Pennsylvania

City: Jefferson Hills RECRUITING
Facility: Jefferson Hospital
Contact Info:
ddefazio@wpahs.org 412-359-3043
Paul B. Renz

City: Monroeville RECRUITING
Facility: Forbes Hospital
Contact Info:
412-858-7746
Paul B. Renz

City: Pittsburgh RECRUITING
Facility: Allegheny General Hospital
Contact Info:
877-284-2000
Paul B. Renz

City: Pittsburgh RECRUITING
Facility: West Penn Hospital
Contact Info:
412-578-5000
Paul B. Renz

City: West Reading RECRUITING
Facility: Reading Hospital
Contact Info:
610-988-9323
Michael L. Haas

Tennessee

City: Collierville RECRUITING
Facility: Baptist Memorial Hospital and Cancer Center-Collierville
Contact Info:
BCCclintrials@bmhcc.org 901-226-1366
Shelby Lane

City: Memphis RECRUITING
Facility: Baptist Memorial Hospital and Cancer Center-Memphis
Contact Info:
BCCclintrials@bmhcc.org 901-226-1366
Shelby Lane

Texas

City: Houston RECRUITING
Facility: Houston Methodist Hospital
Contact Info:
713-790-2700
Kevin T. Tran

City: San Antonio RECRUITING
Facility: University of Texas Health Science Center at San Antonio
Contact Info:
phoresearchoffice@uthscsa.edu 210-450-3800
Amy Le

Virginia

City: Alexandria RECRUITING
Facility: Inova Alexandria Hospital
Contact Info:
Stephanie.VanBebber@inova.org 703-776-2580
Tobias R. Chapman

City: Fairfax RECRUITING
Facility: Inova Schar Cancer Institute
Contact Info:
Stephanie.VanBebber@inova.org 703-720-5210
Tobias R. Chapman

City: Fairfax RECRUITING
Facility: Inova Fair Oaks Hospital
Contact Info:
Stephanie.VanBebber@inova.org 703-720-5210
Tobias R. Chapman

City: Falls Church RECRUITING
Facility: Inova Fairfax Hospital
Contact Info:
Stephanie.VanBebber@inova.org 703-208-6650
Tobias R. Chapman

City: Leesburg RECRUITING
Facility: Inova Loudoun Hospital
Contact Info:
Keary.janet@inova.org 703-858-6000
Tobias R. Chapman

City: Midlothian RECRUITING
Facility: Bon Secours Saint Francis Medical Center
Contact Info:
anne_carmellat@bshsi.org 804-893-8978
Christopher Chipko

City: Richmond RECRUITING
Facility: Bon Secours Saint Mary's Hospital
Contact Info:
anne_carmellat@bshsi.org 804-893-8978
Christopher Chipko

City: Richmond RECRUITING
Facility: Bon Secours Cancer Institute at Reynolds Crossing
Contact Info:
Anne_caramella@bshsi.org 804-893-8978
Christopher Chipko

Vermont

City: Saint Johnsbury RECRUITING
Facility: Dartmouth Cancer Center - North
Contact Info:
cancer.research.nurse@hitchcock.org 800-639-6918
Bassem I. Zaki

Wisconsin

City: Antigo RECRUITING
Facility: Langlade Hospital and Cancer Center
Contact Info:
Juli.Alford@aspirus.org 715-623-9869
Andrew J. Huang

City: Rhinelander RECRUITING
Facility: Aspirus Cancer Care - James Beck Cancer Center
Contact Info:
Beth.Knetter@aspirus.org 715-847-2353
Andrew J. Huang

City: Stevens Point RECRUITING
Facility: Aspirus Cancer Care - Stevens Point
Contact Info:
Beth.Knetter@aspirus.org 715-847-2353
Andrew J. Huang

City: Wausau RECRUITING
Facility: Aspirus Regional Cancer Center
Contact Info:
877-405-6866
Andrew J. Huang

City: Wisconsin Rapids RECRUITING
Facility: Aspirus Cancer Care - Wisconsin Rapids
Contact Info:
715-422-7718
Andrew J. Huang

Treatment

Radiation treatment study for people with locally advanced pancreatic cancer

Clinicaltrials.gov identifier:
NCT06958328

Study Contact Information:

Contact Nina Sanford at: 
Nina.Sanford@UTSouthwestern.edu

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