Clinical Trial 23929

• Overview

  Study Title:

  A PHASE III RANDOMIZED TRIAL OF DOSE ESCALATED RADIATION IN LOCALLY ADVANCED PANCREAS CANCER (LAPC) PATIENTS (LAP100)

  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 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.

  Objective:

  - Evaluate whether dose-escalated radiation therapy (RT) improves 3-year overall survival (OS) compared to standard treatments in patients with locally advanced pancreatic cancer (LAPC) who have not progressed and have shown biochemical response after initial chemotherapy. Secondary objectives: Compare local progression between treatment arms, -Compare progression-free survival (PFS) between treatment arms. -Compare chemotherapy-free interval between treatment arms. -Compare toxicity within and between treatment arms.

• Inclusion Criteria

  Key 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 as defined in the protocol
  • Enrolling at Morton Plant

• Exclusion Criteria

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