A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)

Status: Recruiting
Location: See all (186) locations...
Intervention Type: Procedure, Radiation, Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX (8-12 cycles) or NALIRIFOX (8-12 cycles) or gemcitabine/nab-paclitaxel (4-6 cycles) (1 regimen, no sequential chemotherapy). Active chemotherapy refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of chemotherapy cycle

• BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:

• Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma

• Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network \[NCCN\] guidelines and institutional tumor board review)

• Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, or CT chest/CT pelvis/MRI abdomen performed prior to enrollment

• Age ≥ 18 years

• Performance status Eastern Cooperative Oncology Group (ECOG) 0-2

• Baseline CA19-9 with a normal bilirubin level (defined as ≤ 1.2 mg/dl)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)

• POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:

• If baseline CA19-9 is elevated (defined as \> 37 u/mL) the post-pre-entry chemotherapy CA19-9 must be less than 37 u/mL or a 50% decline from pre-chemotherapy level with absolute value less than 100u/mL

• If baseline CA19-9 is not elevated (defined as ≤ 37 u/mL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u/mL

• No active duodenal or gastric ulcers

• No direct tumor invasion of the bowel or stomach

• Restaging scans showing at least stable disease (no progression). Options for scans include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, or CT chest/CT pelvis/MRI abdomen performed prior to enrollment, with restaging CT showing at least stable disease

• Not pregnant and not nursing

• No cardiac condition that was the primary reason for hospitalization in the last 6 months

• New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)

• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Locations
United States
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
RECRUITING
Jonesboro
Arizona
Arizona Center for Cancer Care - Gilbert
RECRUITING
Gilbert
Arizona Center for Cancer Care-Peoria
RECRUITING
Peoria
Arizona Center for Cancer Care - Phoenix
RECRUITING
Phoenix
Arizona Center for Cancer Care - Scottsdale
RECRUITING
Scottsdale
Arizona Center for Cancer Care-Surprise
RECRUITING
Surprise
Arizona Center for Cancer Care
RECRUITING
Tempe
California
AIS Cancer Center at San Joaquin Community Hospital
RECRUITING
Bakersfield
Alta Bates Summit Medical Center-Herrick Campus
RECRUITING
Berkeley
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
RECRUITING
Cameron Park
Palo Alto Medical Foundation-Fremont
RECRUITING
Fremont
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Irvine
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Memorial Medical Center
RECRUITING
Modesto
Palo Alto Medical Foundation-Camino Division
RECRUITING
Mountain View
UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITING
Orange
Palo Alto Medical Foundation Health Care
RECRUITING
Palo Alto
Sutter Cancer Centers Radiation Oncology Services-Roseville
RECRUITING
Roseville
Sutter Roseville Medical Center
RECRUITING
Roseville
Sutter Medical Center Sacramento
RECRUITING
Sacramento
California Pacific Medical Center-Pacific Campus
RECRUITING
San Francisco
Ridley-Tree Cancer Center
RECRUITING
Santa Barbara
Sutter Pacific Medical Foundation
RECRUITING
Santa Rosa
Palo Alto Medical Foundation-Sunnyvale
RECRUITING
Sunnyvale
Sutter Solano Medical Center/Cancer Center
RECRUITING
Vallejo
BASS Medical Group - Lennon
RECRUITING
Walnut Creek
Colorado
Rocky Mountain Cancer Centers-Boulder
RECRUITING
Boulder
Connecticut
Smilow Cancer Hospital-Derby Care Center
NOT_YET_RECRUITING
Derby
Smilow Cancer Hospital Care Center-Fairfield
NOT_YET_RECRUITING
Fairfield
Smilow Cancer Hospital Care Center at Glastonbury
NOT_YET_RECRUITING
Glastonbury
Smilow Cancer Hospital Care Center at Greenwich
NOT_YET_RECRUITING
Greenwich
Smilow Cancer Hospital Care Center - Guilford
NOT_YET_RECRUITING
Guilford
Smilow Cancer Hospital-Hamden Care Center
RECRUITING
Hamden
Smilow Cancer Hospital Care Center at Saint Francis
NOT_YET_RECRUITING
Hartford
Smilow Cancer Center/Yale-New Haven Hospital
NOT_YET_RECRUITING
New Haven
Yale University
NOT_YET_RECRUITING
New Haven
Yale-New Haven Hospital North Haven Medical Center
NOT_YET_RECRUITING
North Haven
Smilow Cancer Hospital-Torrington Care Center
NOT_YET_RECRUITING
Torrington
Smilow Cancer Hospital Care Center-Trumbull
NOT_YET_RECRUITING
Trumbull
Smilow Cancer Hospital-Waterbury Care Center
NOT_YET_RECRUITING
Waterbury
Smilow Cancer Hospital Care Center - Waterford
NOT_YET_RECRUITING
Waterford
Florida
University of Florida Health Science Center - Gainesville
RECRUITING
Gainesville
Georgia
Memorial Health University Medical Center
SUSPENDED
Savannah
Iowa
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING
Ankeny
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING
Clive
Iowa Methodist Medical Center
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING
Waukee
Illinois
Rush-Copley Medical Center
RECRUITING
Aurora
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Illinois CancerCare-Carthage
RECRUITING
Carthage
Centralia Oncology Clinic
RECRUITING
Centralia
Northwestern University
RECRUITING
Chicago
University of Illinois
RECRUITING
Chicago
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Illinois CancerCare-Eureka
RECRUITING
Eureka
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Illinois CancerCare-Macomb
RECRUITING
Macomb
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
HSHS Saint Elizabeth's Hospital
RECRUITING
O'fallon
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
OSF Saint Francis Medical Center
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
Illinois CancerCare - Washington
RECRUITING
Washington
Indiana
Goshen Center for Cancer Care
RECRUITING
Goshen
Kansas
University of Kansas Cancer Center
RECRUITING
Kansas City
The University of Kansas Cancer Center - Olathe
RECRUITING
Olathe
University of Kansas Cancer Center-Overland Park
RECRUITING
Overland Park
Salina Regional Health Center
RECRUITING
Salina
University of Kansas Health System Saint Francis Campus
RECRUITING
Topeka
University of Kansas Hospital-Westwood Cancer Center
RECRUITING
Westwood
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
Maryland
Sinai Hospital of Baltimore
RECRUITING
Baltimore
William E Kahlert Regional Cancer Center/Sinai Hospital
RECRUITING
Westminster
Maine
MaineHealth Coastal Cancer Treatment Center
RECRUITING
Bath
MaineHealth Maine Medical Center - Portland
RECRUITING
Portland
MaineHealth Cancer Care Center of York County
RECRUITING
Sanford
MaineHealth Maine Medical Center- Scarborough
RECRUITING
Scarborough
MaineHealth Cancer Care and IV Therapy - South Portland
RECRUITING
South Portland
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
University of Michigan Comprehensive Cancer Center
RECRUITING
Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health Medical Center - Brighton
RECRUITING
Brighton
University of Michigan - Brighton Center for Specialty Care
RECRUITING
Brighton
Henry Ford Cancer Institute-Downriver
RECRUITING
Brownstown
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health Medical Center - Canton
RECRUITING
Canton
Chelsea Hospital
RECRUITING
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
Henry Ford Macomb Hospital-Clinton Township
RECRUITING
Clinton Township
Henry Ford Medical Center-Fairlane
RECRUITING
Dearborn
Henry Ford Hospital
RECRUITING
Detroit
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITING
Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Allegiance Health
RECRUITING
Jackson
Beacon Kalamazoo
RECRUITING
Kalamazoo
Bronson Methodist Hospital
RECRUITING
Kalamazoo
West Michigan Cancer Center
RECRUITING
Kalamazoo
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Henry Ford Medical Center-Columbus
RECRUITING
Novi
Michigan Healthcare Professionals Pontiac
RECRUITING
Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
MyMichigan Medical Center Saginaw
RECRUITING
Saginaw
MyMichigan Medical Center Tawas
RECRUITING
Tawas City
Henry Ford West Bloomfield Hospital
RECRUITING
West Bloomfield
Henry Ford Wyandotte Hospital
RECRUITING
Wyandotte
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Missouri
University of Kansas Cancer Center - North
RECRUITING
Kansas City
University of Kansas Cancer Center - Lee's Summit
RECRUITING
Lee's Summit
Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle
RECRUITING
Columbus
Baptist Cancer Center-Grenada
RECRUITING
Grenada
Baptist Memorial Hospital and Cancer Center-Union County
RECRUITING
New Albany
Baptist Memorial Hospital and Cancer Center-Oxford
RECRUITING
Oxford
Baptist Memorial Hospital and Cancer Center-Desoto
RECRUITING
Southhaven
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Nebraska
Nebraska Medicine-Village Pointe
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
Nevada
Renown Regional Medical Center
RECRUITING
Reno
New York
NYU Langone Hospital - Long Island
RECRUITING
Mineola
Mount Sinai Hospital
RECRUITING
New York
Mount Sinai West
RECRUITING
New York
Ohio
Miami Valley Hospital South
RECRUITING
Centerville
University of Cincinnati Cancer Center-UC Medical Center
RECRUITING
Cincinnati
Miami Valley Hospital
RECRUITING
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Miami Valley Cancer Care and Infusion
RECRUITING
Greenville
ProMedica Flower Hospital
RECRUITING
Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
RECRUITING
Toledo
Upper Valley Medical Center
RECRUITING
Troy
University of Cincinnati Cancer Center-West Chester
RECRUITING
West Chester
Pennsylvania
Jefferson Hospital
RECRUITING
Jefferson Hills
Forbes Hospital
RECRUITING
Monroeville
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Allegheny General Hospital
RECRUITING
Pittsburgh
West Penn Hospital
RECRUITING
Pittsburgh
Reading Hospital
RECRUITING
West Reading
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
RECRUITING
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
RECRUITING
Memphis
Texas
Houston Methodist San Jacinto Hospital
RECRUITING
Baytown
MD Anderson in The Woodlands
RECRUITING
Conroe
Houston Methodist Hospital
RECRUITING
Houston
Houston Methodist West Hospital
RECRUITING
Houston
M D Anderson Cancer Center
RECRUITING
Houston
MD Anderson West Houston
RECRUITING
Houston
Methodist Willowbrook Hospital
RECRUITING
Houston
MD Anderson League City
RECRUITING
League City
Houston Methodist Saint John Hospital
RECRUITING
Nassau Bay
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Houston Methodist Sugar Land Hospital
RECRUITING
Sugar Land
MD Anderson in Sugar Land
RECRUITING
Sugar Land
Houston Methodist The Woodlands Hospital
RECRUITING
The Woodlands
Virginia
Inova Alexandria Hospital
RECRUITING
Alexandria
Inova Fair Oaks Hospital
RECRUITING
Fairfax
Inova Schar Cancer Institute
RECRUITING
Fairfax
Inova Fairfax Hospital
RECRUITING
Falls Church
Inova Loudoun Hospital
RECRUITING
Leesburg
Bon Secours Saint Francis Medical Center
RECRUITING
Midlothian
Bon Secours Cancer Institute at Reynolds Crossing
RECRUITING
Richmond
Bon Secours Saint Mary's Hospital
RECRUITING
Richmond
Vermont
Dartmouth Cancer Center - North
RECRUITING
Saint Johnsbury
Wisconsin
Langlade Hospital and Cancer Center
RECRUITING
Antigo
Medical College of Wisconsin
RECRUITING
Milwaukee
Aspirus Cancer Care - James Beck Cancer Center
RECRUITING
Rhinelander
Aspirus Cancer Care - Stevens Point
RECRUITING
Stevens Point
Aspirus Regional Cancer Center
RECRUITING
Wausau
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING
Wisconsin Rapids
Time Frame
Start Date: 2025-08-21
Estimated Completion Date: 2030-10-21
Participants
Target number of participants: 356
Treatments
Active_comparator: Arm I (Options 1, 2, or 3)
See Detailed Description.
Experimental: Arm II (dose-escalated RT)
Patients undergo dose-escalated RT daily, every other day, or twice weekly for 5 fractions or daily for 25 fractions (with or without concurrent fluorouracil or capecitabine for 25 fractions only). The 5-fraction regimen is preferred when feasible. After completing dose-escalated RT, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion. Additionally, patients undergo blood sample collection, CT, MRI and tumor tissue biopsy throughout the study.
Related Therapeutic Areas
Sponsors
Leads: NRG Oncology

This content was sourced from clinicaltrials.gov

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