Home › Trials › NCT06958328

Higher-dose targeted radiation for locally advanced pancreatic cancer

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

Phase 3 Interventional NRG Oncology · NCT06958328

This tests whether giving a higher, precisely targeted dose of radiation after initial chemotherapy helps people with locally advanced unresectable pancreatic cancer live longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment356 (estimated)
Ages18 Years and up
SexAll
SponsorNRG Oncology Academic / other
Drugs / interventionschemotherapy, radiation
Locations279 sites (Gilbert, Arizona and 278 other locations)
Trial IDNCT06958328 on ClinicalTrials.gov

What this trial studies

This randomized phase III trial enrolls patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have completed 4–6 months of initial chemotherapy without radiographic progression and with biochemical response. Participants are randomized to dose-escalated, precisely delivered radiation therapy versus standard care, where standard care may include additional chemotherapy, observation, or conventional lower-dose radiation. The primary endpoint is three-year overall survival, with secondary endpoints including local progression, progression-free survival, chemotherapy-free interval, toxicity, and health-related quality of life measured by FACT-Hep. The protocol also includes biospecimen collection for future correlative studies.

Who should consider this trial

Good fit: Adults with pathologically confirmed locally advanced unresectable pancreatic ductal adenocarcinoma who have completed 4–6 months of initial chemotherapy without radiographic progression and demonstrate biochemical response are eligible.

Not a fit: Patients whose disease progressed during initial chemotherapy, those who are surgical candidates, or those unable to tolerate radiation are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, higher-dose targeted radiation could extend survival and slow tumor growth after initial chemotherapy for people with locally advanced pancreatic cancer.

How similar studies have performed: Limited prior studies and retrospective reports suggest dose escalation can improve local control, but randomized phase III evidence showing a survival benefit in this setting is currently lacking.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Gilbert, Arizona and 278 other locations

+229 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced Unresectable Pancreatic Ductal AdenocarcinomaStage II Pancreatic Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.