Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
Recruiting · NCT06958328 · Interventional (participants receive a specific treatment) · Lead sponsor: NRG Oncology
View the official record on ClinicalTrials.gov →Interventions studied
Biopsy ProcedureBiospecimen CollectionCapecitabineComputed TomographyDose-escalated Radiation TherapyFluorouracilGemcitabineIrinotecan HydrochlorideIrinotecan SucrosofateLeucovorin CalciumMagnetic Resonance ImagingNab-paclitaxelObservation ActivityOxaliplatinPositron Emission TomographyQuestionnaire AdministrationRadiation TherapyTumor Treating Fields Therapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine/nab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for toxicity reasons, but not for disease progression. "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, CT chest/CT pelvis/MRI abdomen, or PET/CT performed prior to enrollment
- Age ≥ 18 years
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
- Required initial laboratory values:
- All laboratory values must be obtained any time prior to initiation of chemotherapy up to 30 days post initiation of chemotherapy
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
- BASELINE CA19-9 AND BILIRUBIN REQUIREMENTS: The purpose is to obtain a baseline CA19-9 in the setting of a normal (or close to normal) bilirubin, since serologic response by serial CA19-9 measurements is part of post-chemotherapy eligibility criteria
- If baseline CA19-9 \> 37 U/mL the concurrent bilirubin must be ≤ 1.5 x ULN. (Note: if the bilirubin is not ≤ 1.5 x ULN both the CA19-9 and concurrent bilirubin can be repeated until bilirubin is ≤ 1.5 x ULN, as long as done within specified timeframe \[up to 30 days post chemotherapy initiation\])
- If baseline CA19-9 U/mL ≤ 37, there are no restrictions on the required concurrent bilirubin level, and this can be the accepted baseline value
- Prior radiation treatment
- Has the patient had prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Prior non-overlapping radiation (e.g., breast, head and neck, extremity) is permitted
- If uncertain about prior overlap, please contact the study principal investigator, Dr. Nina Sanford
- 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, or PET/CT 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
Where it is running
60 locations listed across 42 US states.
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Arizona Center for Cancer Care - Gilbert - Gilbert, Arizona, United States
- Arizona Center for Cancer Care-Peoria - Peoria, Arizona, United States
- Arizona Center for Cancer Care - Phoenix - Phoenix, Arizona, United States
- Arizona Center for Cancer Care - Scottsdale - Scottsdale, Arizona, United States
- Arizona Center for Cancer Care-Surprise - Surprise, Arizona, United States
- Arizona Center for Cancer Care - Tempe, Arizona, United States
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro, Arkansas, United States
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande, California, United States
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield, California, United States
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley, California, United States
- Mills-Peninsula Medical Center - Burlingame, California, United States
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park, California, United States
- Palo Alto Medical Foundation-Fremont - Fremont, California, United States
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine, California, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- Memorial Medical Center - Modesto, California, United States
- Palo Alto Medical Foundation-Camino Division - Mountain View, California, United States
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange, California, United States
- Palo Alto Medical Foundation Health Care - Palo Alto, California, United States
- Stanford Cancer Institute Palo Alto - Palo Alto, California, United States
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville, California, United States
- Sutter Roseville Medical Center - Roseville, California, United States
- Sutter Medical Center Sacramento - Sacramento, California, United States
- California Pacific Medical Center-Pacific Campus - San Francisco, California, United States
- Mills Health Center - San Mateo, California, United States
- Ridley-Tree Cancer Center - Santa Barbara, California, United States
- Mission Hope Medical Oncology - Santa Maria - Santa Maria, California, United States
- Sutter Pacific Medical Foundation - Santa Rosa, California, United States
- Palo Alto Medical Foundation-Sunnyvale - Sunnyvale, California, United States
- Sutter Solano Medical Center/Cancer Center - Vallejo, California, United States
- BASS Medical Group - Lennon - Walnut Creek, California, United States
- Rocky Mountain Cancer Centers-Boulder - Boulder, Colorado, United States
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs, Colorado, United States
- UCHealth Memorial Hospital Central - Colorado Springs, Colorado, United States
- Memorial Hospital North - Colorado Springs, Colorado, United States
- AdventHealth Porter - Denver, Colorado, United States
- AdventHealth Littleton - Littleton, Colorado, United States
- AdventHealth Parker - Parker, Colorado, United States
- Danbury Hospital - Danbury, Connecticut, United States
- Smilow Cancer Hospital-Derby Care Center - Derby, Connecticut, United States
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield, Connecticut, United States
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury, Connecticut, United States
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich, Connecticut, United States
- Smilow Cancer Hospital Care Center - Guilford - Guilford, Connecticut, United States
- Smilow Cancer Hospital-Hamden Care Center - Hamden, Connecticut, United States
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford, Connecticut, United States
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven, Connecticut, United States
- Yale University - New Haven, Connecticut, United States
- Yale-New Haven Hospital North Haven Medical Center - North Haven, Connecticut, United States
- Norwalk Hospital - Norwalk, Connecticut, United States
- Smilow Cancer Hospital-Torrington Care Center - Torrington, Connecticut, United States
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull, Connecticut, United States
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury, Connecticut, United States
- Smilow Cancer Hospital Care Center - Waterford - Waterford, Connecticut, United States
- Helen F Graham Cancer Center - Newark, Delaware, United States
- Medical Oncology Hematology Consultants PA - Newark, Delaware, United States
- Christiana Care Health System-Christiana Hospital - Newark, Delaware, United States
- Christiana Care Health System-Wilmington Hospital - Wilmington, Delaware, United States
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
Showing 60 of 322 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →