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Status:

RECRUITING

Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

Lead Sponsor:

NRG Oncology

Conditions:

Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma

Stage II Pancreatic Cancer AJCC v8

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 ...

Detailed Description

PRIMARY OBJECTIVE: I. To evaluate whether dose-escalated radiation therapy (RT) improves 3-year overall survival (OS) compared to standard treatments without dose-escalated RT, in locally advanced pa...

Eligibility Criteria

Inclusion

  • 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/MRI abdomen performed prior to enrollment
  • Age ≥ 18 years
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
  • Baseline CA19-9 with a normal bilirubin level (defined as ≤ 1.2 mg/dl)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)
  • 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 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

Exclusion

    Key Trial Info

    Start Date :

    August 21 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 21 2030

    Estimated Enrollment :

    356 Patients enrolled

    Trial Details

    Trial ID

    NCT06958328

    Start Date

    August 21 2025

    End Date

    October 21 2030

    Last Update

    November 10 2025

    Active Locations (186)

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    Page 1 of 47 (186 locations)

    1

    Arizona Center for Cancer Care - Gilbert

    Gilbert, Arizona, United States, 85297

    2

    Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, United States, 85381

    3

    Arizona Center for Cancer Care - Phoenix

    Phoenix, Arizona, United States, 85027

    4

    Arizona Center for Cancer Care - Scottsdale

    Scottsdale, Arizona, United States, 85258