RECRUITING

Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

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Conditions

Locally Advanced Unresectable Pancreatic Ductal AdenocarcinomaStage II Pancreatic Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-21
Study Completion:2030-10-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06958328

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
  3. * Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma
  4. * Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network \[NCCN\] guidelines and institutional tumor board review)
  5. * 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
  6. * Age ≥ 18 years
  7. * Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
  8. * Baseline CA19-9 with a normal bilirubin level (defined as ≤ 1.2 mg/dl)
  9. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)
  10. * POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
  11. * 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
  12. * If baseline CA19-9 is not elevated (defined as ≤ 37 u/mL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u/mL
  13. * No active duodenal or gastric ulcers
  14. * No direct tumor invasion of the bowel or stomach
  15. * 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
  16. * Not pregnant and not nursing
  17. * No cardiac condition that was the primary reason for hospitalization in the last 6 months
  18. * 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.)
  19. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Nina N Sanford
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, 85297
United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381
United States
Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona, 85027
United States
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, 85258
United States
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, 85374
United States
Arizona Center for Cancer Care
Tempe, Arizona, 85284
United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301
United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
United States
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538
United States
Memorial Medical Center
Modesto, California, 95355
United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040
United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661
United States
Sutter Roseville Medical Center
Roseville, California, 95661
United States
Sutter Medical Center Sacramento
Sacramento, California, 95816
United States
Ridley-Tree Cancer Center
Santa Barbara, California, 93105
United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403
United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086
United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589
United States
BASS Medical Group - Lennon
Walnut Creek, California, 94598
United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
Rush-Copley Medical Center
Aurora, Illinois, 60504
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526
United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland, 21157
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Allegiance Health
Jackson, Michigan, 49201
United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560
United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
United States
Forbes Hospital
Monroeville, Pennsylvania, 15146
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
Reading Hospital
West Reading, Pennsylvania, 19611
United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304
United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
United States
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
Inova Loudoun Hospital
Leesburg, Virginia, 20176
United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: NRG Oncology

  • Nina N Sanford, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-21
Study Completion Date2030-10-21

Study Record Updates

Study Start Date2025-08-21
Study Completion Date2030-10-21

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma
  • Stage II Pancreatic Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8