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Testing Higher Dose Radiation for Locally Advanced Pancreatic Cancer

This study is testing if a higher dose of radiation therapy, called dose-escalated radiation therapy, can help people with locally advanced pancreatic cancer live longer. You might be able to join if you have locally advanced pancreatic cancer that cannot be removed by surgery and have already received 4-6 months of chemotherapy (like FOLFIRINOX, NALIRIFOX, or gemcitabine/nab-paclitaxel). The study will compare this higher dose radiation to usual care options, which could include more chemotherapy, observation, or standard lower-dose radiation. The main goal is to see if dose-escalated radiation therapy improves how long people live. The current status of this study is unclear, and it plans to enroll 356 participants.

Study design
This is an interventional study that plans to enroll 356 participants. Participants will be randomly assigned to receive either dose-escalated radiation therapy or standard treatments.
What's involved
You would undergo a tumor tissue biopsy, blood sample collection, and imaging tests like CT or PET/CT scans. You may also receive the drug Capecitabine.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured from randomization to the date of death or last follow-up, assessed for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06958328

Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
NRG Oncology
~356 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionCapecitabineComputed TomographyDose-escalated Radiation TherapyFluorouracil

At a glance

Recruiting sites
327 of 333 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over From randomization to the date of death or last follow-up, assessed up to 3 years

Conditions

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

Explore related trials

Pancreatic Ductal AdenocarcinomaCA19-9

NCT06958328

Where you'd take part

This study runs at 333 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Littleton

    Littleton, Coloradostudy coordinator listed

    Recruiting

  • AdventHealth Orlando

    Orlando, Floridastudy coordinator listed

    Recruiting

  • AdventHealth Parker

    Parker, Coloradostudy coordinator listed

    Recruiting

  • AdventHealth Porter

    Denver, Coloradostudy coordinator listed

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinoisstudy coordinator listed

    Recruiting

  • Advocate High Tech Medical Park

    Palos Heights, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nina N Sanford · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
602-747-9738
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Eligibility criteria

Inclusion

At time of enrollment, the patient must have received 4-8 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine/nab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for reasons other than radiographic progression by Response Evaluation Criteria in Solid Tumors (RECIST) (i.e. chemotherapy regimen switch is allowed for toxicity, and/or switch is allowed for toxicity and/or CA19-9 level not declining). Patients are allowed to receive chemotherapy after restaging scans, as long as 1) restaging scans are performed after at least 4 months of chemotherapy and 2) the total chemotherapy duration does not exceed 8 months
"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 pre-study entry chemotherapy
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:
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 200 u/mL OR a 70% decline from pre-chemotherapy level (i.e. a patient with post induction chemotherapy CA199 value ≥ 200 u/mL would qualify, as long as they had at least 70% drop from baseline CA199 value; similarly, a patient with less than a 70% decline would qualify as long as absolute value post induction chemotherapy is under 200 u/mL) (must be completed any time post month 4 of chemotherapy and prior to study entry)
If baseline CA19-9 is not elevated (defined as ≤ 37 u/mL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u/mL (must be completed any time post month 4 of chemotherapy and prior to study entry)
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

What this trial measures

  • Overall survival (OS)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).