NCT06958328 · NRG Oncology
Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
(LAP100)
What this study 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.
View original scientific 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.
Interventions
PROCEDURE
Biopsy Procedure
Undergo tumor tissue biopsy
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
DRUG
Capecitabine
Given capecitabine
PROCEDURE
Computed Tomography
Undergo CT or PET/CT
RADIATION
Dose-escalated Radiation Therapy
Undergo dose-escalated radiation using intensity-modulated radiation therapy treatment planning
DRUG
Fluorouracil
Given fluorouracil
DRUG
Gemcitabine
Given gemcitabine
DRUG
Irinotecan Hydrochloride
Given irinotecan hydrochloride
DRUG
Irinotecan Sucrosofate
Given liposomal irinotecan
DRUG
Leucovorin Calcium
Given leucovorin calcium
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
DRUG
Nab-paclitaxel
Given nab-paclitaxel
OTHER
Observation Activity
Undergo observation
DRUG
Oxaliplatin
Given oxaliplatin
PROCEDURE
Positron Emission Tomography
Undergo PET/CT
OTHER
Questionnaire Administration
Ancillary studies
RADIATION
Radiation Therapy
Undergo standard radiation therapy
Primary outcome measures
Overall survival (OS)
Time frame: From randomization to the date of death or last follow-up, assessed up to 3 years
OS will be estimated by the Kaplan-Meier method (Kaplan 1958). The 3-year OS estimates between the two arms will be compared using a Z-test. A logistic regression model will be used to analyze the effects of factors, in addition to treatment, including, but not limited to the stratification factor, which may be associated with 3-year OS. The primary hypothesis of improved 3-year OS will be tested with a 1-sided significance level of 0.023 (level based on not having stopped at either of the 2 planned interim analyses).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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/MR
Where
- Gilbert, Arizona
- Peoria, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Surprise, Arizona
- Tempe, Arizona
- Jonesboro, Arkansas
- Arroyo Grande, California
- Bakersfield, California
- Berkeley, California
- Burlingame, California
- Cameron Park, California
And 235 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations