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NRG-GI011: A PHASE III RANDOMIZED TRIAL OF DOSE ESCALATED RADIATION IN LOCALLY ADVANCED PANCREAS CANCER (LAPC) PATIENTS (LAP100)

Primary Investigator
Cuneo, Kyle
Status
OPEN TO ACCRUAL
Phase
III
NCT Number
NCT06958328
UM Number
2025.079
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Gastrointestinal Oncology
ID (Protocol)
62571
Secondary Protocol No
HUM00277069
Scope
Unspecified
Sponsor Type
National
Disease Site
Pancreas
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.

Eligibility: 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